IU Health Methodist Clinical Research

Clinical research at Indiana University Health Methodist Hospital supports basic and clinical research through a broad range of services to improve clinical outcomes, quality of life, and cost-effective patient care. The Institute embodies the traditional strengths and values of IU Health Methodist Hospital, while supporting the current and evolving strategies of IU Health.

Medical research, an integral part of IU Health Methodist Hospital since the hospital’s founding in 1908, became a formal department in 1956. When Methodist Hospital, Indiana University Hospital and Riley Hospital for Children consolidated to form IU Health in 1997, the Department of Medical Research was reorganized as the Methodist Research Institute.

Its rich history includes the following:

  • Pioneering work in solid organ transplantation
  • Midwest training location for the DaVinci Robotic Surgical System
  • Testing of minimally invasive surgical techniques
  • Development of laparoscopic bladder augmentation using small intestinal submucosa (SIS)
  • Work in the health policy arena (including development and testing of the 1st globally-priced heart surgery reimbursement model for Medicare)

Today, Methodist is home to a biorepository, a medical research laboratory, a clinical research group, and support services that include statistical consulting, data registry management, editing, and biomedical illustration.

About

Medical research, an integral part of IU Health Methodist Hospital since the hospital’s founding in 1908, became a formal department in 1956. When Methodist Hospital, Indiana University Hospital and Riley Hospital for Children consolidated to form IU Health in 1997, the Department of Medical Research was reorganized as the Methodist Research Institute.

Its rich history includes the following:

  • Pioneering work in solid organ transplantation
  • Midwest training location for the DaVinci Robotic Surgical System
  • Testing of minimally invasive surgical techniques
  • Development of laparoscopic bladder augmentation using small intestinal submucosa (SIS)
  • Work in the health policy arena (including development and testing of the 1st globally-priced heart surgery reimbursement model for Medicare)

Today, Methodist is home to a biorepository, a medical research laboratory, a clinical research group, and support services that include statistical consulting, data registry management, editing, and biomedical illustration.

Further information regarding clinical research studies approved by the FDA can be found at ClinicalTrials.gov. For interest in being a healthy subject volunteer please call 317.278.2176.

Indiana University Health Methodist Hospital

  • PI/Dept: Bhakta, Cardiology
  • Study Title: Understanding outcomes with the EMBLEM™ S-ICD in primary prevention patients with low ejection fraction UNTOUCHED)
  • NCT #: NCT02433379 
  • IRB #: 1508589568
  • Age/Condition: ≥ 21 yrs, Ventricular fibrillation, ventricular tachycardia, low cardiac output
  • Purpose: To assess the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.


  • PI/Dept: Corvera, Surgery 
  • Study Title – CytoSorb reduction of free hemoglobin/acute kidney 
    injury (AKI) during cardiac surgery
  • NCT # – NCT03384875
  • IRB # – 1808848583
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of AKI in the first 48 hours after surgery when used intraoperatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery.

 

  • PI/Dept: Corvera, Surgery 
  • Study Title –  A prospective, multicenter, non-blinded, non-randomized study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers 
  • NCT #: NCT02818972
  • IRB #: 1607573902
  • Age/Condition: ≥ 18 yrs 
  • Purpose: Investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.


  • PI/Dept: Corvera, Surgery
  • Study Title – A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Traumatic Injury of the Descending Thoracic Aorta
  • NCT #: NCT03090230
  • IRB #: 1704025451
  • Age/Condition: ≥ 18 yrs, Traumatic injury to DTA no more than 30 days prior to planned stent implantation
  • Purpose: To investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA).


  • PI/Dept: Duncan, Pulmonary 
  • Study Title – Pulmonary arterial hypertension Uptravi (SelexiPag): The Users Drug Registry (SPHERE)
  • IRB #: 1609390966
  • Age/Condition: Adults


  • PI/Dept: Duncan, Pulmonary
  • Study Title – Oral treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF)
  • NCT #: NCT03037580
  • IRB #: 1703740295 TDE-HF-301
  • Age/Condition: 8 yrs to 79 yrs
  • Purpose: A multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).


  • PI/Dept: Duncan, Pulmonary
  • Study Title – An open-label extension study of oral Treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF) - A long-term follow-up to study TDE-HF-301 
  • NCT #: NCT03043651
  • IRB #: 1703912764; TDE-HF-302
  • Age/Condition: 18 yrs to 79 yrs 
  • Purpose: To evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).


  • PI/Dept: Fajardo, Surgery
  • Study Title – Clinical investigation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation (PRESERVE)
  • NCT #: NCT01208415
  • IRB #: 1403948759
  • Age/Condition: ≥ 18 yrs, Aorto-iliac aneurysms, illiac aneurysms
  • Purpose: To study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.


  • PI/Dept: Garcia, Surgery
  • Study Title – A clinical trial to evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
  • IRB #: 1309182139
  • NCT#: NCT01966458
  • Age/Condition: ≥ 18 yrs, Chronic heart failure
  • Purpose: To evaluate the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management.


  • PI/Dept: Garcia, Surgery
  • Study Title – Novel lung trial: normothermic ex vivo lung perfusion (Evlp) as an assessment of extended/marginal donor lungs
  • NCT #: NCT01365429
  • IRB #: 1302010599
  • Age/Condition: ≥ 18 yrs, Lung transplant
  • Purpose: Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.


  • PI/Dept: Garcia, Surgery
  • Study Title – XVIVO Perfusion System (XPS) with Steen Solution Perfusate (XVIVO HDE)
  • IRB #: 1612590156
  • Age/Condition: Adults
  • PI/Dept: Geraci, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Evaluation of reactivity of mononuclear cells to collagen V in lung transplant patients
  • IRB #: 1105005473
  • Age/Condition: Adults
  • Purpose: To evaluate reactivity of mononuclear cells to collagen V in lung transplant patients.


  • PI/Dept: Hage, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title: Pathogenesis and molecular mechanisms underlying pulmonary diseases
  • IRB #: 1803517135
  • Age/Condition: Adults


  • PI/Dept: Hage, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Extracorporeal photopheresis for the management of progressive bronchiolitis obliterans syndrome in medicare-eligible recipients of lung allografts
  • NCT #: NCT02181257
  • IRB #: 1412113692
  • Age/Condition: ≥ 18 yrs, Bronchiolitis obliterans syndrome (BOS)
  • Purpose: To determine if Extracorporeal Photopheresis (ECP) is effective in the treatment of progressive Bronchiolitis Obliterans Syndrome (BOS) in patients after lung transplantation. 


  • PI/Dept: Hage, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Observational disease registry of patients treated with systemic mold-active triazoles
  • IRB #:1608845528
  • NCT#: NCT03066011
  • Age/Condition: ≥ 18 yrs (<18 yrs with parent or legal guardian consent) 
  • Purpose: To describe representative real-world patterns of care for the management of invasive fungal infections (IFIs), including invasive mold infection (IMI)—specifically, to examine real world patient characteristics and treatment patterns, associated healthcare resource utilization, and outcomes associated with use of mold-active triazoles (MATs) to treat IFIs.


  • PI/Dept: Hage, Medicine – pulmonary, critical care, sleep & occupational medicine
  • Study Title: A non-interventional registry study of systemic antifungal therapy in adult subjects with invasive mucormycosis or invasive aspergillosis caused by a non-fumigatus species
  • IRB #: 1608839771
  • Age/Condition: Adults


  • PI/Dept: Hage, Medicine – pulmonary, critical care, sleep & occupational medicine
  • Study Title – Donor smoke exposure and the relationship to primary graft dysfunction
  • IRB #: 1410508609
  • Age/Condition: Adults


  • PI/Dept: Harvey, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – An open-label extension of BPS-314d-MR-PAH-302 in pulmonary arterial hypertension patients (BEAT-OLE)
  • NCT#: NCT03657095
  • IRB #: BPS-314d-MR-PAH-303
  • Age/Condition: 18 Years to 85 Years
  • Purpose: This is a multi-center, open-label study for eligible subjects who were actively participating in the BPS-314d-MR-PAH-302 study at the time the study was concluded. This OLE study will evaluate the safety, tolerability and efficacy of long-term treatment of the esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets) study drug.


  • PI/Dept: Harvey, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – A phase 3, randomized, placebo-controlled, 
    double-blind, adaptive study to evaluate the safety and efficacy 
    of inhaled Treprostinil in patients with pulmonary 
    hypertension due to chronic obstructive pulmonary disease (PH-COPD)
  • NCT#: NCT03496623
  • IRB #: RIN-PH-304
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from Baseline 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in subjects with PH-COPD


  • PI/Dept: Harvey, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – US-based, observational, drug registry of Opsumit® (macitentan) new users in clinical practice (OPsumit Users Registry)
  • NCT#: NCT02126943
  • IRB #: 1403636387
  • Age/Condition: Child, Adult, Older Adult 
  • Purpose: To characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting


  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
  • NCT#: NCT031908688
  • IRB #: 1707334701
  • Age/Condition: Child, Adult, Older Adults
  • Purpose: To characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.


  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – Beraprost-314d added-on to Tyvaso® (BEAT)
  • NCT#: NCT01908699
  • IRB #: 1310454500
  • Age/Condition: 18 yrs to 80 yrs, Pulmonary arterial hypertension
  • Purpose: To assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension.


  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – Safety and efficacy of inhaled treprostinil in adult PH with ILD Including CPFE (INCREASE)
  • NCT#: NCT02630316
  • IRB #: 1602009422
  • Age/Condition: 18 yrs to 79 yrs, Pulmonary hypertension, interstitial lung disease, combined pulmonary fibrosis and emphysema
  • Purpose: To evaluate the safety and efficacy of inhaled
    treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE)


  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – An open-label extension study of inhaled treprostinil in subjects with pulmonary hypertension due to parenchymal lung disease (INCREASE OL)
  • NCT#: NCT02633293
  • IRB #: 1602009433
  • Age/Condition: ≥ 18 yrs, Pulmonary hypertension, interstitial lung disease, combined pulmonary fibrosis and emphysema 
  • Purpose: To evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 75 clinical trial centers.


  • PI/Dept: House, Surgery
  • Study Title – Prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot® Polysaccharide Hemostatic System
  • NCT#: NCT02359994
  • IRB #: 1408941961
  • Age/Condition: ≥ 22 yrs, Blood loss, surgical 
  • Purpose: To evaluate the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.


  • PI/Dept: Kapoor, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – A randomized, double-blind, placebo-controlled, phase 3 study to assess the safety and efficacy of art-123 in subjects with sepsis and coagulopathy
  • NCT#: NCT03517501
  • IRB #: 3-3002
  • Age/Condition: ≥ 18 yrs, Severe sepsis, coagulopathy 
  • Purpose: To evaluate whether ART-123, when administered to subjects with bacterial infection complicated by at least one organ dysfunction (cardiac or respiratory) and coagulopathy, can reduce mortality.


  • PI/Dept: Kelton, Medicine - general internal medicine and geriatrics
  • Study Title – Expanded Access IND Program to Provide Stamaril® Vaccine to Persons in the United States for Vaccination Against Yellow Fever
  • IRB #: 1704191374


  • PI/Dept: Lahm, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects with Pulmonary Arterial Hypertension (PAH) (PRIME-X)
  • NCT#: NCT03449524
  • IRB #: 1808050442
  • Age/Condition: 18 - 80 yrs
  • Purpose: 1) To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 3 months in subjects with PAH assessed by right ventricular ejection fraction (RVEF) as measured by cardiac MRI. 2) To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 3 months in subjects with PAH assessed by pulmonary vascular resistance (PVR) as measured by right heart catheterization (RHC)


  • PI/Dept: Lahm, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – National biological sample and data repository for pulmonary arterial hypertension
  • IRB # : 1411663529
  • Age/Condition: Adults


  • PI/Dept: Machado, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – A phase 1 clinical trial of ABI-009, an mTOR inhibitor, for patients with severe pulmonary arterial hypertension (PAH) (ABI-009 PAH study)
  • NCT#: NCT02587325
  • IRB #: 1802341349
  • Age/Condition: ≥ 18 yrs
  • Purpose: To determine number of participants with treatment-related adverse events as assessed by CTCAE v4.0.


  • PI/Dept: Mariash, Medicine, endocrinology
  • Study Title – An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
  • NCT#: NCT02804750
  • IRB #: 1804047163
  • Age/Condition: 18 yrs to 75 yrs 
  • Purpose: To assess the long-term safety of relacorilant in the treatment of the signs and symptoms of endogenous Cushing syndrome.


  • PI/Dept: Mariash, Medicine, endocrinology
  • Study Title – Development of a Biorepository for Methodist Research Institute (MRI Biorepository)
  • IRB #: 1011004282
  • Age/Condition: Adults


  • PI/Dept: Mariash, Medicine, endocrinology
  • Study Title – Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushings Syndrome (CORCEPT Cushings Study)
  • NCT#: NCT02804750
  • IRB #: 1609334377; CORT125134-451
  • Age/Condition: 18 yrs to 80 yrs 
  • Purpose: To evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome.


  • PI/Dept: Mariash, Medicine, endocrinology
  • Study Title – Medtronic product surveillance registry base protocol  
  • NCT#: NCT01524276
  • IRB #: 1204008386
  • Age/Condition: Child, Adult, Senior 
  • Purpose: To provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment.


  • PI/Dept: Murphy, Cardiology
  • Study Title – Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF)
  • NCT#: NCT02501811
  • IRB #: 1509192628
  • Age/Condition: 21 yrs to 79 yrs 
  • Purpose: To assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.


  • PI/Dept: Pang, Medicine, cardiology
  • Study Title – Evaluate the safety and efficacy of 48-hour infusions of HNO (nitroxyl) donor in hospitalized patients with heart failure (STANDUP AHF)
  • NCT#: NCT03016325
  • IRB #: 1611169140
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To evaluate safety and efficacy of continuous 48-hour intravenous infusions of HNO donor in hospitalized patients with heart failure and impaired systolic function


  • PI/Dept: Revtyak, Medicine - cardiology
  • Study Title –  A multinational, randomized double-blind placebo-controlled trial to evaluate the effect of Ticagrelor 90 mg twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus
  • NCT#: NCT01991795
  • IRB #: 1403942864; D513BC00001
  • Age/Condition: 50 yrs to 130 yrs 
  • Purpose: The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus


  • PI/Dept: Roe, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility (EVP-CLES)
  • NCT#: NCT03641677
  • IRB #: EVP-DEV-LTX-301
  • Age/Condition: adults
  • Purpose: The objective of this study is to evaluate the safety and effectiveness of the CLES in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 6 months or hospital discharge post-transplant.


  • PI/Dept: Roe, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Protocol for the collection and transfer of cystic fibrosis lungs for research purposes (CF Lung)
  • IRB #: 1010002276


  • PI/Dept: Sinha, Medicine, cardiology
  • Study Title – The PARTNER II trial: Placement of Aortic Transcatheter valves
  • NCT#: NCT01314313
  • IRB #: 1209009610
  • Age/Condition: ≥ 19 yrs
  • Purpose: To determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems, which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.


  • PI/Dept: Wang, Cardiology
  • Study Title – Clinical study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension after left ventricular assist device implantation (Soprano)
  • NCT#: NCT02554903
  • IRB #: 1510320657
  • Age/Condition: ≥ 18 yrs
  • Purpose: To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation


  • PI/Dept: Wang, Surgery
  • Study Title – A prospective, single arm, multi-center clinical study in collaboration with the interagency registry for mechanically assisted circulatory support (INTERMACS®) to evaluate the thoracotomy implant technique of the HeartWare HVAD® System in patients with advanced heart failure. (HVAD Lateral)
  • NCT#: NCT02268942
  • IRB #: 1411712195
  • Age/Condition: ≥ 19 yrs, Left-sided heart failure 
  • Purpose: To evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD® System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) protocol and database.


  • PI/Dept: Wang, Surgery
  • Study Title – SynCardia 50cc temporary total artificial heart (TAH-t) as a bridge to transplant (BTT)
  • NCT#: NCT02459054
  • IRB #: 1605941156
  • Age/Condition: ≥ 10 yrs, Heart failure, right-sided, cardiac failure, heart failure, left-sided
  • Purpose: To evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support transplant-eligible adult patients (aged 19 - 75 years) at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits.


  • PI/Dept: Wang, Surgery
  • Study Title – Momentum 3 multi-center study of MagLev technology in patients undergoing MCS therapy with Heartmate 3
  • NCT#: NCT02224755
  • IRB #: 1504262012
  • Age/Condition: 18 yrs to 100 yrs 
  • Purpose: The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.


  • PI/Dept: Wang, Surgery
  • Study Title – International EXPAND heart pivotal trial (EXPANDHeart)
  • NCT#: NCT02323321
  • IRB #: 1509924992
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart.


  • PI/Dept: Williams, Medicine - pulmonary, critical care, sleep and occupational medicine
  • Study Title – Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD (VENT-AVOID)
  • NCT#: NCT03255057
  • IRB #: HL-CA-5000
  • Age/Condition: ≥ 22 yrs 
  • Purpose: To evaluate the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).


  • PI/Dept: Williams, Medicine - pulmonary, critical care, sleep and occupational medicine
  • Study Title – Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS)
  • NCT#: NCT03434028
  • IRB #: 1802093803; PETAL03 CLOVERS
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.


  • PI/Dept: Williams, Medicine - pulmonary, critical care, sleep and occupational medicine
  • Study Title – Evaluation of fluid volume in patients with sepsis and refractory hypotension (CHEETAH FRESH)
  • NCT#: NCT02837731
  • IRB #: 1710717532; PRO-0001
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.

Clinical Trials

Further information regarding clinical research studies approved by the FDA can be found at ClinicalTrials.gov. For interest in being a healthy subject volunteer please call 317.278.2176.

Indiana University Health Methodist Hospital

  • PI/Dept: Bhakta, Cardiology
  • Study Title: Understanding outcomes with the EMBLEM™ S-ICD in primary prevention patients with low ejection fraction UNTOUCHED)
  • NCT #: NCT02433379 
  • IRB #: 1508589568
  • Age/Condition: ≥ 21 yrs, Ventricular fibrillation, ventricular tachycardia, low cardiac output
  • Purpose: To assess the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.


  • PI/Dept: Corvera, Surgery 
  • Study Title – CytoSorb reduction of free hemoglobin/acute kidney 
    injury (AKI) during cardiac surgery
  • NCT # – NCT03384875
  • IRB # – 1808848583
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of AKI in the first 48 hours after surgery when used intraoperatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery.

 

  • PI/Dept: Corvera, Surgery 
  • Study Title –  A prospective, multicenter, non-blinded, non-randomized study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers 
  • NCT #: NCT02818972
  • IRB #: 1607573902
  • Age/Condition: ≥ 18 yrs 
  • Purpose: Investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.


  • PI/Dept: Corvera, Surgery
  • Study Title – A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Traumatic Injury of the Descending Thoracic Aorta
  • NCT #: NCT03090230
  • IRB #: 1704025451
  • Age/Condition: ≥ 18 yrs, Traumatic injury to DTA no more than 30 days prior to planned stent implantation
  • Purpose: To investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA).


  • PI/Dept: Duncan, Pulmonary 
  • Study Title – Pulmonary arterial hypertension Uptravi (SelexiPag): The Users Drug Registry (SPHERE)
  • IRB #: 1609390966
  • Age/Condition: Adults


  • PI/Dept: Duncan, Pulmonary
  • Study Title – Oral treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF)
  • NCT #: NCT03037580
  • IRB #: 1703740295 TDE-HF-301
  • Age/Condition: 8 yrs to 79 yrs
  • Purpose: A multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).


  • PI/Dept: Duncan, Pulmonary
  • Study Title – An open-label extension study of oral Treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF) - A long-term follow-up to study TDE-HF-301 
  • NCT #: NCT03043651
  • IRB #: 1703912764; TDE-HF-302
  • Age/Condition: 18 yrs to 79 yrs 
  • Purpose: To evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).


  • PI/Dept: Fajardo, Surgery
  • Study Title – Clinical investigation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation (PRESERVE)
  • NCT #: NCT01208415
  • IRB #: 1403948759
  • Age/Condition: ≥ 18 yrs, Aorto-iliac aneurysms, illiac aneurysms
  • Purpose: To study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.


  • PI/Dept: Garcia, Surgery
  • Study Title – A clinical trial to evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
  • IRB #: 1309182139
  • NCT#: NCT01966458
  • Age/Condition: ≥ 18 yrs, Chronic heart failure
  • Purpose: To evaluate the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management.


  • PI/Dept: Garcia, Surgery
  • Study Title – Novel lung trial: normothermic ex vivo lung perfusion (Evlp) as an assessment of extended/marginal donor lungs
  • NCT #: NCT01365429
  • IRB #: 1302010599
  • Age/Condition: ≥ 18 yrs, Lung transplant
  • Purpose: Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.


  • PI/Dept: Garcia, Surgery
  • Study Title – XVIVO Perfusion System (XPS) with Steen Solution Perfusate (XVIVO HDE)
  • IRB #: 1612590156
  • Age/Condition: Adults
  • PI/Dept: Geraci, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Evaluation of reactivity of mononuclear cells to collagen V in lung transplant patients
  • IRB #: 1105005473
  • Age/Condition: Adults
  • Purpose: To evaluate reactivity of mononuclear cells to collagen V in lung transplant patients.


  • PI/Dept: Hage, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title: Pathogenesis and molecular mechanisms underlying pulmonary diseases
  • IRB #: 1803517135
  • Age/Condition: Adults


  • PI/Dept: Hage, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Extracorporeal photopheresis for the management of progressive bronchiolitis obliterans syndrome in medicare-eligible recipients of lung allografts
  • NCT #: NCT02181257
  • IRB #: 1412113692
  • Age/Condition: ≥ 18 yrs, Bronchiolitis obliterans syndrome (BOS)
  • Purpose: To determine if Extracorporeal Photopheresis (ECP) is effective in the treatment of progressive Bronchiolitis Obliterans Syndrome (BOS) in patients after lung transplantation. 


  • PI/Dept: Hage, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Observational disease registry of patients treated with systemic mold-active triazoles
  • IRB #:1608845528
  • NCT#: NCT03066011
  • Age/Condition: ≥ 18 yrs (<18 yrs with parent or legal guardian consent) 
  • Purpose: To describe representative real-world patterns of care for the management of invasive fungal infections (IFIs), including invasive mold infection (IMI)—specifically, to examine real world patient characteristics and treatment patterns, associated healthcare resource utilization, and outcomes associated with use of mold-active triazoles (MATs) to treat IFIs.


  • PI/Dept: Hage, Medicine – pulmonary, critical care, sleep & occupational medicine
  • Study Title: A non-interventional registry study of systemic antifungal therapy in adult subjects with invasive mucormycosis or invasive aspergillosis caused by a non-fumigatus species
  • IRB #: 1608839771
  • Age/Condition: Adults


  • PI/Dept: Hage, Medicine – pulmonary, critical care, sleep & occupational medicine
  • Study Title – Donor smoke exposure and the relationship to primary graft dysfunction
  • IRB #: 1410508609
  • Age/Condition: Adults


  • PI/Dept: Harvey, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – An open-label extension of BPS-314d-MR-PAH-302 in pulmonary arterial hypertension patients (BEAT-OLE)
  • NCT#: NCT03657095
  • IRB #: BPS-314d-MR-PAH-303
  • Age/Condition: 18 Years to 85 Years
  • Purpose: This is a multi-center, open-label study for eligible subjects who were actively participating in the BPS-314d-MR-PAH-302 study at the time the study was concluded. This OLE study will evaluate the safety, tolerability and efficacy of long-term treatment of the esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets) study drug.


  • PI/Dept: Harvey, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – A phase 3, randomized, placebo-controlled, 
    double-blind, adaptive study to evaluate the safety and efficacy 
    of inhaled Treprostinil in patients with pulmonary 
    hypertension due to chronic obstructive pulmonary disease (PH-COPD)
  • NCT#: NCT03496623
  • IRB #: RIN-PH-304
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from Baseline 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in subjects with PH-COPD


  • PI/Dept: Harvey, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – US-based, observational, drug registry of Opsumit® (macitentan) new users in clinical practice (OPsumit Users Registry)
  • NCT#: NCT02126943
  • IRB #: 1403636387
  • Age/Condition: Child, Adult, Older Adult 
  • Purpose: To characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting


  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
  • NCT#: NCT031908688
  • IRB #: 1707334701
  • Age/Condition: Child, Adult, Older Adults
  • Purpose: To characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.


  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – Beraprost-314d added-on to Tyvaso® (BEAT)
  • NCT#: NCT01908699
  • IRB #: 1310454500
  • Age/Condition: 18 yrs to 80 yrs, Pulmonary arterial hypertension
  • Purpose: To assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension.


  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – Safety and efficacy of inhaled treprostinil in adult PH with ILD Including CPFE (INCREASE)
  • NCT#: NCT02630316
  • IRB #: 1602009422
  • Age/Condition: 18 yrs to 79 yrs, Pulmonary hypertension, interstitial lung disease, combined pulmonary fibrosis and emphysema
  • Purpose: To evaluate the safety and efficacy of inhaled
    treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE)


  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – An open-label extension study of inhaled treprostinil in subjects with pulmonary hypertension due to parenchymal lung disease (INCREASE OL)
  • NCT#: NCT02633293
  • IRB #: 1602009433
  • Age/Condition: ≥ 18 yrs, Pulmonary hypertension, interstitial lung disease, combined pulmonary fibrosis and emphysema 
  • Purpose: To evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 75 clinical trial centers.


  • PI/Dept: House, Surgery
  • Study Title – Prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot® Polysaccharide Hemostatic System
  • NCT#: NCT02359994
  • IRB #: 1408941961
  • Age/Condition: ≥ 22 yrs, Blood loss, surgical 
  • Purpose: To evaluate the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.


  • PI/Dept: Kapoor, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – A randomized, double-blind, placebo-controlled, phase 3 study to assess the safety and efficacy of art-123 in subjects with sepsis and coagulopathy
  • NCT#: NCT03517501
  • IRB #: 3-3002
  • Age/Condition: ≥ 18 yrs, Severe sepsis, coagulopathy 
  • Purpose: To evaluate whether ART-123, when administered to subjects with bacterial infection complicated by at least one organ dysfunction (cardiac or respiratory) and coagulopathy, can reduce mortality.


  • PI/Dept: Kelton, Medicine - general internal medicine and geriatrics
  • Study Title – Expanded Access IND Program to Provide Stamaril® Vaccine to Persons in the United States for Vaccination Against Yellow Fever
  • IRB #: 1704191374


  • PI/Dept: Lahm, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects with Pulmonary Arterial Hypertension (PAH) (PRIME-X)
  • NCT#: NCT03449524
  • IRB #: 1808050442
  • Age/Condition: 18 - 80 yrs
  • Purpose: 1) To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 3 months in subjects with PAH assessed by right ventricular ejection fraction (RVEF) as measured by cardiac MRI. 2) To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 3 months in subjects with PAH assessed by pulmonary vascular resistance (PVR) as measured by right heart catheterization (RHC)


  • PI/Dept: Lahm, Medicine- pulmonary, critical care, sleep & occupational medicine
  • Study Title – National biological sample and data repository for pulmonary arterial hypertension
  • IRB # : 1411663529
  • Age/Condition: Adults


  • PI/Dept: Machado, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – A phase 1 clinical trial of ABI-009, an mTOR inhibitor, for patients with severe pulmonary arterial hypertension (PAH) (ABI-009 PAH study)
  • NCT#: NCT02587325
  • IRB #: 1802341349
  • Age/Condition: ≥ 18 yrs
  • Purpose: To determine number of participants with treatment-related adverse events as assessed by CTCAE v4.0.


  • PI/Dept: Mariash, Medicine, endocrinology
  • Study Title – An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
  • NCT#: NCT02804750
  • IRB #: 1804047163
  • Age/Condition: 18 yrs to 75 yrs 
  • Purpose: To assess the long-term safety of relacorilant in the treatment of the signs and symptoms of endogenous Cushing syndrome.


  • PI/Dept: Mariash, Medicine, endocrinology
  • Study Title – Development of a Biorepository for Methodist Research Institute (MRI Biorepository)
  • IRB #: 1011004282
  • Age/Condition: Adults


  • PI/Dept: Mariash, Medicine, endocrinology
  • Study Title – Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushings Syndrome (CORCEPT Cushings Study)
  • NCT#: NCT02804750
  • IRB #: 1609334377; CORT125134-451
  • Age/Condition: 18 yrs to 80 yrs 
  • Purpose: To evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome.


  • PI/Dept: Mariash, Medicine, endocrinology
  • Study Title – Medtronic product surveillance registry base protocol  
  • NCT#: NCT01524276
  • IRB #: 1204008386
  • Age/Condition: Child, Adult, Senior 
  • Purpose: To provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment.


  • PI/Dept: Murphy, Cardiology
  • Study Title – Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF)
  • NCT#: NCT02501811
  • IRB #: 1509192628
  • Age/Condition: 21 yrs to 79 yrs 
  • Purpose: To assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.


  • PI/Dept: Pang, Medicine, cardiology
  • Study Title – Evaluate the safety and efficacy of 48-hour infusions of HNO (nitroxyl) donor in hospitalized patients with heart failure (STANDUP AHF)
  • NCT#: NCT03016325
  • IRB #: 1611169140
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To evaluate safety and efficacy of continuous 48-hour intravenous infusions of HNO donor in hospitalized patients with heart failure and impaired systolic function


  • PI/Dept: Revtyak, Medicine - cardiology
  • Study Title –  A multinational, randomized double-blind placebo-controlled trial to evaluate the effect of Ticagrelor 90 mg twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus
  • NCT#: NCT01991795
  • IRB #: 1403942864; D513BC00001
  • Age/Condition: 50 yrs to 130 yrs 
  • Purpose: The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus


  • PI/Dept: Roe, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility (EVP-CLES)
  • NCT#: NCT03641677
  • IRB #: EVP-DEV-LTX-301
  • Age/Condition: adults
  • Purpose: The objective of this study is to evaluate the safety and effectiveness of the CLES in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 6 months or hospital discharge post-transplant.


  • PI/Dept: Roe, Medicine - pulmonary, critical care, sleep & occupational medicine
  • Study Title – Protocol for the collection and transfer of cystic fibrosis lungs for research purposes (CF Lung)
  • IRB #: 1010002276


  • PI/Dept: Sinha, Medicine, cardiology
  • Study Title – The PARTNER II trial: Placement of Aortic Transcatheter valves
  • NCT#: NCT01314313
  • IRB #: 1209009610
  • Age/Condition: ≥ 19 yrs
  • Purpose: To determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems, which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.


  • PI/Dept: Wang, Cardiology
  • Study Title – Clinical study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension after left ventricular assist device implantation (Soprano)
  • NCT#: NCT02554903
  • IRB #: 1510320657
  • Age/Condition: ≥ 18 yrs
  • Purpose: To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation


  • PI/Dept: Wang, Surgery
  • Study Title – A prospective, single arm, multi-center clinical study in collaboration with the interagency registry for mechanically assisted circulatory support (INTERMACS®) to evaluate the thoracotomy implant technique of the HeartWare HVAD® System in patients with advanced heart failure. (HVAD Lateral)
  • NCT#: NCT02268942
  • IRB #: 1411712195
  • Age/Condition: ≥ 19 yrs, Left-sided heart failure 
  • Purpose: To evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD® System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) protocol and database.


  • PI/Dept: Wang, Surgery
  • Study Title – SynCardia 50cc temporary total artificial heart (TAH-t) as a bridge to transplant (BTT)
  • NCT#: NCT02459054
  • IRB #: 1605941156
  • Age/Condition: ≥ 10 yrs, Heart failure, right-sided, cardiac failure, heart failure, left-sided
  • Purpose: To evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support transplant-eligible adult patients (aged 19 - 75 years) at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits.


  • PI/Dept: Wang, Surgery
  • Study Title – Momentum 3 multi-center study of MagLev technology in patients undergoing MCS therapy with Heartmate 3
  • NCT#: NCT02224755
  • IRB #: 1504262012
  • Age/Condition: 18 yrs to 100 yrs 
  • Purpose: The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.


  • PI/Dept: Wang, Surgery
  • Study Title – International EXPAND heart pivotal trial (EXPANDHeart)
  • NCT#: NCT02323321
  • IRB #: 1509924992
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart.


  • PI/Dept: Williams, Medicine - pulmonary, critical care, sleep and occupational medicine
  • Study Title – Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD (VENT-AVOID)
  • NCT#: NCT03255057
  • IRB #: HL-CA-5000
  • Age/Condition: ≥ 22 yrs 
  • Purpose: To evaluate the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).


  • PI/Dept: Williams, Medicine - pulmonary, critical care, sleep and occupational medicine
  • Study Title – Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS)
  • NCT#: NCT03434028
  • IRB #: 1802093803; PETAL03 CLOVERS
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.


  • PI/Dept: Williams, Medicine - pulmonary, critical care, sleep and occupational medicine
  • Study Title – Evaluation of fluid volume in patients with sepsis and refractory hypotension (CHEETAH FRESH)
  • NCT#: NCT02837731
  • IRB #: 1710717532; PRO-0001
  • Age/Condition: ≥ 18 yrs 
  • Purpose: To assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.