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Current Clinical Research Activities

Sponsored Studies – On-going

  • MINT: Myocardial Ischemia and transfusion: Randomized study to examine the outcomes of a restrictive (Hb<7-8 g/dl) versus liberal transfusion strategy in patients who have sustained an acute myocardial infarction. NIH trial via subcontract with Rutgers University. The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic. Start date - April 2017, PI: Robert Hendel, MD

  • EMPEROR-Reduced & Preserved: These are 2 concurrent Phase III randomized, double-blind trial evaluating the efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patient with chronic heart failure with reduced or preserved ejection fraction (HFrEF/HFpEF – Boehringer-Ingelheim). The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo, on top of guideline-directed medical therapy, in patients with heart failure with preserved or reduced ejection fraction. Start date - August 2017, PI: Keith Ferdinand, MD

  • Heart-FID: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency (Luitpold Pharmaceuticals Inc). The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction. Start date – September 2017, PI: Anand Irimpen, MD

  • GRAHF 2: Genomic Analysis of Enhanced Response to Heart Failure Therapy in African Americans (NIH-sponsored via subcontract with Univ. of Pittsburg) The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. Start date - January 2016, PI: Keith Ferdinand, MD

Sponsored Studies – Pending

  • BIO-Libra: AnaLysIs of Both Sex and Device Specific FactoRs on Outcomes in PAtients with Non-Ischemic Cardiomyopathy. (BIOTRONIK) A multi-center, observational study designed to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type. The BIO-LIBRA Study. PI: Colleen Johnson, MD

  • Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF - United Therapeutics Corp.) The primary objective of this study is to assess the effect of oral treprostinil compared with placebo on change in exercise capacity as measured by change in 6-Minute Walk Distance (6MWD) from Baseline to Week 24 in subjects with PH associated with HFpEF. PI: Thierry Le Jemtel, MD

  • WARRIOR: Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (Department of Defense via subcontract with Univ. of Florida) A multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) evaluating intensive statin/ACE-I (or ARB)/aspirin treatment (IMT) vs. usual care (UC) in 4,422 symptomatic women patients with symptoms and/or signs of ischemia but no obstructive CAD. PI: Robert Hendel, MD

Investigator-Initiated Studies

  • PROGRESS_CTO: Multi center Registry of Chronic Total Occlusion Interventions. Start date – January 2016, PI: Atul Singla, MD

  • GraftMaster RX: Coronary Stent Graft system (Humanitarian Use Device for Emergency Use in Coronary Artery Perforation). Start date – Before 2009, PI: Anand Irimpen, MD

  • Relationship between optimal LDL-C levels and risk of CAD (Chart Review at TMC). Start date – May 2019, PI: Achal Sahai, MD

  • Predictive ability of non-invasive cardiac stress testing in assessing cardiac related outcomes in end stage renal disease (Chart Review at TMC). Start date – May 2019, PI: Atul Singla, MD

  • Katrina-MI study: Incidence of Myocardial Infarction Before and After Hurricane Katrina At Primary Angioplasty Centers in New Orleans, Louisiana (Chart Review at TMC). Start date – August 2007, PI: Anand Irimpen, MD

  • Qualitative angiographic characteristics of coronary anatomy in patients presenting with ST- Elevation myocardial infarction (Chart Review at TMC). Start date – May 2019, PI: Achal Sahai, MD

  • Papyrus-PKCovered Coronary Stent System - BIOTRONIK (Humanitarian Use Device for Emergency Use in Coronary Artery Perforation). Start date – February 2019, PI: Anand Irimpen, MD