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Cardiology Research

Study Title: US-based, Observational, Drug Registry Opsumit® (macitentan) new users in clinical practice (OPUS) (Identifier: NCT02126943)

Study Purpose:  Prospective observational drug registry developed 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

Principal Investigator: Samer Khouri, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, of call 419.383.3853


Study Title:   A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF) (Identifier: NCT03037580)

Study Purpose:  This is 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). Once randomized, subjects will take the initial dose of study drug at the study site on the day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.

Principal Investigator: Samer Khouri, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, of call 419.383.3853


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 TDE-HF-301 (Identifier: NCT03043651)

Study Purpose:  This is an open-label study 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). Subject visits will occur at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil becomes commercially available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.

Principal Investigator: Samer Khouri, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, of call 419.383.3853


Study Title:   Myocardial Ischemia and Transfusion (MINT).  (Identifier: NCT02981407)

Study Purpose:  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.

Principal Investigator: Mujeeb Sheikh, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, of call 419.383.3853


Study Title:   The Randomized and Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil Drug-Coated Balloon in the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon (TRANSCEND Study).  (Identifier: NCT03241459)

Study Purpose:  This trial will evaluate the safety and effectiveness of a newly developed drug-coated balloon (DCB) catheter, the Surmodics SurVeil DCB, in the treatment of narrowing within an artery in the thigh.  The study will test how well the SurVeil DCB catheter performs in treating this narrowing compared to the Food and Drug Administration (FDA) approved Medtronic IN.PACT Admiral DCB catheter.

Principal Investigator: Mark Burket, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, of call 419.383.3853


Study Title:   A Phase III Randomised, Double-Blind Trial to Evaluate Efficacy and Safety of One Daily Empagliflozin 10 mg Compared to Placebo, in Patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).  (EMPEROR-Reduced)  (Identifier: NCT03057977)

Study Purpose:  The purpose of this study is to investigate the clinical efficacy (how well something works to treat a condition) and safety of the study drug in treating subjects who have a type of chronic heart failure (HF) that includes reduced Ejection Fraction (HFrEF).  This study will tell us if empagliflozin can reduce hospitalizations related to heart failure and cardiac associated death compared to placebo (a "dummy treatment" which looks like empagliflozin but contains no active ingredients) in subjects with HF receiving appropriate care.

Principal Investigator: Samer Khouri, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, of call 419.383.3853


 

Study Title:   A Phase III Randomised, Double-Blind Trial to Evaluate Efficacy and Safety of One Daily Empagliflozin 10 mg Compared to Placebo, in Patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF).  (EMPEROR-Preserved)  (Identifier: NCT03057951)

Study Purpose:  The purpose of this study is to investigate the clinical efficacy (how well something works to treat a condition) and safety of the study drug in treating subjects who have a type of chronic heart failure (HF) that includes reduced Ejection Fraction (HFpEF).  This study will tell us if empagliflozin can reduce hospitalizations related to heart failure and cardiac associated death compared to placebo (a "dummy treatment" which looks like empagliflozin but contains no active ingredients) in subjects with HF receiving appropriate care.

Principal Investigator: Samer Khouri, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, of call 419.383.3853


 

 

Last Updated: 3/26/18