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

  • IRB # –Study Title – NCT#: 1508589568 – Understanding outcomes with the EMBLEM™ S-ICD in primary prevention patients with low ejection fraction UNTOUCHED) NCT02433379
  • PI/Dept: Bhakta Cardiology
  • 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.


  • IRB # –Study Title – NCT#: 1607573902 – 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 NCT02818972
  • PI/Dept: Corvera Surgery 
  • 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


  • IRB # –Study Title – NCT#: 1704025451 – 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 NCT03090230
  • PI/Dept: Corvera, Surgery 
  • 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)


  • IRB # –Study Title – NCT#: 1609390966 – Pulmonary Arterial Hypertension Uptravi (SelexiPag):The Users Drug Registry
  • PI/Dept: Duncan, Cardiology  


  • IRB # –Study Title – NCT#: TDE-HF-301 – Oral treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF) NCT03037580 
  • PI/Dept: Duncan, Cardiology 18 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).


  • IRB # –Study Title – NCT#: TDE-HF-302 – Study of oral treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF) NCT03043651 
  • PI/Dept: Duncan, Cardiology
  • 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).


  • IRB # –Study Title – NCT#: 1403948759 – Clinical investigation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation (PRESERVE), NCT01208415 
  • PI/Dept: Fajardo, Surgery 
  • 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.


  • IRB # –Study Title – NCT#: 1105005473 – Evaluation of reactivity of mononuclear cells to collagen V in lung transplant patients
  • PI/Dept: Geraci, Medicine- pulmonary, critical care, sleep & occupational medicine 
  • Purpose: To evaluate reactivity of mononuclear cells to collagen V in lung transplant patients.


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


  • IRB # –Study Title – NCT#: 1608845528 – Observational disease registry of patients treated with systemic mold-active triazoles 
  • PI/Dept: Hage, Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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.


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


  • IRB # –Study Title – NCT#: 1412113692 – Extracorporeal photopheresis for the management of progressive bronchiolitis obliterans syndrome in medicare-eligible recipients of lung allografts NCT02181257
  • PI/Dept: Hage, Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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.


  • IRB # –Study Title – NCT#: 1403636387 – Opsumit Users Registry NCT02126943
  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Age/Condition: Pulmonary arterial hypertension 
  • 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.


  • IRB # –Study Title – NCT#: 1310454500 – Beraprost-314d added-on to Tyvaso® (BEAT) NCT01908699
  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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.


  • IRB # –Study Title – NCT#: 1602009422 – Safety and efficacy of inhaled treprostinil in adult PH with ILD Including CPFE (INCREASE) NCT02630316
  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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)


  • IRB # –Study Title – NCT#: 1602009433 – An open-label extension study of inhaled treprostinil in subjects with pulmonary hypertension due to parenchymal lung disease (INCREASE OL) NCT02633293
  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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.


  • IRB # –Study Title – NCT#: 1707334701 – Multicenter, retrospective chart review of first-time Opsumit (macitentan) users in the United States (OrPHeUS) NCT03197688
  • PI/Dept: Harvey, Medicine- pulmonary, critical care, sleep & occupational medicine Child, Adult, Senior
  • Purpose: The study is being done to further characterize the safety profile for Opsumit, primarily potential serious hepatic risks. Any patient who was a first-time user of Opsumit from October 2013- December 31, 2016.


  • IRB # –Study Title – NCT#: 1408941961 – Prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot® Polysaccharide Hemostatic System, NCT02359994
  • PI/Dept: House, Surgery 
  • 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.


  • IRB # –Study Title – NCT#: 1506963342 – Phase 3 safety and efficacy study of ART-123 in subjects with severe sepsis and coagulopathy NCT01598831
  • PI/Dept: Kapoor Medicine- pulmonary, critical care, sleep & occupational medicine 
  • Age/Condition: ≥ 18 yrs, Severe sepsis, coagulopathy 
  • Purpose: To evaluate if ART-123 given to patients who have severe sepsis complicated by at least one organ dysfunction and coagulopathy can decrease mortality.


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


  • IRB # –Study Title – NCT#: CORT125134-451 – Phase 2 study of the safety and efficacy of CORT125134 in the treatment of endogenous Cushings syndrome, NCT02804750
  • PI/Dept: Mariash, Medicine, endocrinology 
  • Age/Condition: 18 yrs to 75 yrs 
  • Purpose: The purpose of this multi-center study is to evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome.


  • IRB # –Study Title – NCT#: 1204008386 – Medtronic product surveillance registry base protocol NCT01524276
  • PI/Dept: Mariash, Medicine, endocrinology 
  • 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.


  • IRB # –Study Title – NCT#: 1509192628 – Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF) NCT02501811 
  • PI/Dept: Murphy, Cardiology 
  • 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.


  • IRB # –Study Title – NCT#: 1611169140 – Evaluate the safety and efficacy of 48-hour infusions of HNO (nitroxyl) donor in hospitalized patients with heart failure (STANDUP AHF) NCT03016325 
  • PI/Dept: Pang, Medicine, cardiology 
  • 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


  • IRB # –Study Title – NCT#: 1403942864; D513BC00001 – 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 NCT01991795
  • PI/Dept: Revtyak, Medicine, cardiology
  • 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


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

 

  • IRB # –Study Title – NCT#: 1209009610 – The PARTNER II trial: Placement of Aortic Transcatheter valves NCT01314313
  • PI/Dept: Sinha Cardiology 
  • Age/Condition: Symptomatic severe aortic stenosis
  • 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.


  • IRB # –Study Title – NCT#: 1510320657 – Clinical study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension after left ventricular assist device implantation (Soprano) NCT02554903
  • PI/Dept: Wang, Cardiology 
  • Age/Condition: ≥ 50 yrs
  • Purpose: Pulmonary hypertension 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


  • IRB # –Study Title – NCT#: 1605941156 – SynCardia 50cc temporary total artificial heart (TAH-t) as a bridge to transplant (BTT) NCT02459054
  • PI/Dept: Wang, Surgery 
  • 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.


  • IRB # –Study Title – NCT#: 1504262012 – Momentum 3 Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with Heartmate 3 NCT02224755
  • PI/Dept: Wang, Surgery
  • 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.


  • IRB # –Study Title – NCT#: 1509924992 – International EXPAND heart pivotal trial (EXPANDHeart) NCT02323321 
  • PI/Dept: Wang, Surgery 
  • 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


  • IRB # –Study Title – NCT#: 1610689278 – Reevaluation of systemic early neuromuscular blockade (ROSE) NCT02509078 
  • PI/Dept: Williams, Medicine- pulmonary, critical care, sleep & occupational medicine 
  • Age/Condition: ≥ 18 yrs To evaluate whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival.


  • IRB # –Study Title – NCT#: 1411712195 – 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) NCT02268942
  • PI/Dept: Wosniak, Surgery 
  • 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


  • IRB # –Study Title – NCT#: 1309182139 – A clinical trial to evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) NCT01966458
  • PI/Dept: Wozniak, Surgery 
  • 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.


  • IRB # –Study Title – NCT#: 1011003773 – A clinical trial to evaluate the HeartWare® Ventricular Assist System (ENDURANCE) NCT01166347
  • PI/Dept: Wozniak, Surgery 
  • Age/Condition: ≥ 18 yrs, Chronic heart failure
  • Purpose: To determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.


  • IRB # –Study Title – NCT#: 1212010179 – Post-approval study on patients who received a HeartWare HVAD® during IDE trials (PAS) NCT01832610
  • PI/Dept: Wozniak, Surgery 
  • Age/Condition: ≥ 18 yrs, Heart failure
  • Purpose: Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.


  • IRB # –Study Title – NCT#: 1302010599 – Novel lung trial: normothermic ex vivo lung perfusion (Evlp) as an assessment of extended/marginal donor lungs NCT01365429
  • PI/Dept: Wozniak, Surgery 
  • 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.

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

  • IRB # –Study Title – NCT#: 1508589568 – Understanding outcomes with the EMBLEM™ S-ICD in primary prevention patients with low ejection fraction UNTOUCHED) NCT02433379
  • PI/Dept: Bhakta Cardiology
  • 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.


  • IRB # –Study Title – NCT#: 1607573902 – 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 NCT02818972
  • PI/Dept: Corvera Surgery 
  • 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


  • IRB # –Study Title – NCT#: 1704025451 – 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 NCT03090230
  • PI/Dept: Corvera, Surgery 
  • 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)


  • IRB # –Study Title – NCT#: 1609390966 – Pulmonary Arterial Hypertension Uptravi (SelexiPag):The Users Drug Registry
  • PI/Dept: Duncan, Cardiology  


  • IRB # –Study Title – NCT#: TDE-HF-301 – Oral treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF) NCT03037580 
  • PI/Dept: Duncan, Cardiology 18 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).


  • IRB # –Study Title – NCT#: TDE-HF-302 – Study of oral treprostinil in subjects with pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF) NCT03043651 
  • PI/Dept: Duncan, Cardiology
  • 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).


  • IRB # –Study Title – NCT#: 1403948759 – Clinical investigation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation (PRESERVE), NCT01208415 
  • PI/Dept: Fajardo, Surgery 
  • 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.


  • IRB # –Study Title – NCT#: 1105005473 – Evaluation of reactivity of mononuclear cells to collagen V in lung transplant patients
  • PI/Dept: Geraci, Medicine- pulmonary, critical care, sleep & occupational medicine 
  • Purpose: To evaluate reactivity of mononuclear cells to collagen V in lung transplant patients.


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


  • IRB # –Study Title – NCT#: 1608845528 – Observational disease registry of patients treated with systemic mold-active triazoles 
  • PI/Dept: Hage, Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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.


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


  • IRB # –Study Title – NCT#: 1412113692 – Extracorporeal photopheresis for the management of progressive bronchiolitis obliterans syndrome in medicare-eligible recipients of lung allografts NCT02181257
  • PI/Dept: Hage, Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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.


  • IRB # –Study Title – NCT#: 1403636387 – Opsumit Users Registry NCT02126943
  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine
  • Age/Condition: Pulmonary arterial hypertension 
  • 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.


  • IRB # –Study Title – NCT#: 1310454500 – Beraprost-314d added-on to Tyvaso® (BEAT) NCT01908699
  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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.


  • IRB # –Study Title – NCT#: 1602009422 – Safety and efficacy of inhaled treprostinil in adult PH with ILD Including CPFE (INCREASE) NCT02630316
  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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)


  • IRB # –Study Title – NCT#: 1602009433 – An open-label extension study of inhaled treprostinil in subjects with pulmonary hypertension due to parenchymal lung disease (INCREASE OL) NCT02633293
  • PI/Dept: Harvey Medicine- pulmonary, critical care, sleep & occupational medicine 
  • 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.


  • IRB # –Study Title – NCT#: 1707334701 – Multicenter, retrospective chart review of first-time Opsumit (macitentan) users in the United States (OrPHeUS) NCT03197688
  • PI/Dept: Harvey, Medicine- pulmonary, critical care, sleep & occupational medicine Child, Adult, Senior
  • Purpose: The study is being done to further characterize the safety profile for Opsumit, primarily potential serious hepatic risks. Any patient who was a first-time user of Opsumit from October 2013- December 31, 2016.


  • IRB # –Study Title – NCT#: 1408941961 – Prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot® Polysaccharide Hemostatic System, NCT02359994
  • PI/Dept: House, Surgery 
  • 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.


  • IRB # –Study Title – NCT#: 1506963342 – Phase 3 safety and efficacy study of ART-123 in subjects with severe sepsis and coagulopathy NCT01598831
  • PI/Dept: Kapoor Medicine- pulmonary, critical care, sleep & occupational medicine 
  • Age/Condition: ≥ 18 yrs, Severe sepsis, coagulopathy 
  • Purpose: To evaluate if ART-123 given to patients who have severe sepsis complicated by at least one organ dysfunction and coagulopathy can decrease mortality.


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


  • IRB # –Study Title – NCT#: CORT125134-451 – Phase 2 study of the safety and efficacy of CORT125134 in the treatment of endogenous Cushings syndrome, NCT02804750
  • PI/Dept: Mariash, Medicine, endocrinology 
  • Age/Condition: 18 yrs to 75 yrs 
  • Purpose: The purpose of this multi-center study is to evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome.


  • IRB # –Study Title – NCT#: 1204008386 – Medtronic product surveillance registry base protocol NCT01524276
  • PI/Dept: Mariash, Medicine, endocrinology 
  • 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.


  • IRB # –Study Title – NCT#: 1509192628 – Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF) NCT02501811 
  • PI/Dept: Murphy, Cardiology 
  • 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.


  • IRB # –Study Title – NCT#: 1611169140 – Evaluate the safety and efficacy of 48-hour infusions of HNO (nitroxyl) donor in hospitalized patients with heart failure (STANDUP AHF) NCT03016325 
  • PI/Dept: Pang, Medicine, cardiology 
  • 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


  • IRB # –Study Title – NCT#: 1403942864; D513BC00001 – 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 NCT01991795
  • PI/Dept: Revtyak, Medicine, cardiology
  • 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


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

 

  • IRB # –Study Title – NCT#: 1209009610 – The PARTNER II trial: Placement of Aortic Transcatheter valves NCT01314313
  • PI/Dept: Sinha Cardiology 
  • Age/Condition: Symptomatic severe aortic stenosis
  • 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.


  • IRB # –Study Title – NCT#: 1510320657 – Clinical study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension after left ventricular assist device implantation (Soprano) NCT02554903
  • PI/Dept: Wang, Cardiology 
  • Age/Condition: ≥ 50 yrs
  • Purpose: Pulmonary hypertension 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


  • IRB # –Study Title – NCT#: 1605941156 – SynCardia 50cc temporary total artificial heart (TAH-t) as a bridge to transplant (BTT) NCT02459054
  • PI/Dept: Wang, Surgery 
  • 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.


  • IRB # –Study Title – NCT#: 1504262012 – Momentum 3 Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with Heartmate 3 NCT02224755
  • PI/Dept: Wang, Surgery
  • 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.


  • IRB # –Study Title – NCT#: 1509924992 – International EXPAND heart pivotal trial (EXPANDHeart) NCT02323321 
  • PI/Dept: Wang, Surgery 
  • 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


  • IRB # –Study Title – NCT#: 1610689278 – Reevaluation of systemic early neuromuscular blockade (ROSE) NCT02509078 
  • PI/Dept: Williams, Medicine- pulmonary, critical care, sleep & occupational medicine 
  • Age/Condition: ≥ 18 yrs To evaluate whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival.


  • IRB # –Study Title – NCT#: 1411712195 – 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) NCT02268942
  • PI/Dept: Wosniak, Surgery 
  • 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


  • IRB # –Study Title – NCT#: 1309182139 – A clinical trial to evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) NCT01966458
  • PI/Dept: Wozniak, Surgery 
  • 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.


  • IRB # –Study Title – NCT#: 1011003773 – A clinical trial to evaluate the HeartWare® Ventricular Assist System (ENDURANCE) NCT01166347
  • PI/Dept: Wozniak, Surgery 
  • Age/Condition: ≥ 18 yrs, Chronic heart failure
  • Purpose: To determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.


  • IRB # –Study Title – NCT#: 1212010179 – Post-approval study on patients who received a HeartWare HVAD® during IDE trials (PAS) NCT01832610
  • PI/Dept: Wozniak, Surgery 
  • Age/Condition: ≥ 18 yrs, Heart failure
  • Purpose: Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.


  • IRB # –Study Title – NCT#: 1302010599 – Novel lung trial: normothermic ex vivo lung perfusion (Evlp) as an assessment of extended/marginal donor lungs NCT01365429
  • PI/Dept: Wozniak, Surgery 
  • 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.