A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients with Heart Failure and Impaired Systolic Function Save

Date Added
March 28th, 2017
PRO Number
Pro00063152
Researcher
Adrian Van Bakel
Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety, and effectiveness of BMS-986231 (HNO DONOR) in patients with acute heart failure when added to the standard treatment. Reduced strength of contraction can mean that your heart is not pumping most of the blood out of your heart with each beat. The study drug will be given as a continuous 48-hour infusion (through an IV) during the hospital stay. There will be a follow up visit at 30 days. All adults who meet inclusion criteria will be approached for this study.

Institution
MUSC
Recruitment Contact
Anna Tecklenburg
8437925863
tecklenb@musc.edu

Genomic Analysis of Enhanced Response to Heart Failure Therapy in African Americans Save

Date Added
March 15th, 2016
PRO Number
Pro00051247
Researcher
Adrian Van Bakel
Keywords
Cardiovascular, Drug Studies
Summary

It is well known heart failure remains a major cause of cardiovascular morbidity and mortality among African Americans. It is also known the effectiveness of certain heart failure therapeutics appears to be distinctively different in black and white cohorts. Based on previous studies, 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. The purpose of this study is to see if African American with a specific genotype would benefit from this therapy. If so in the future it may be feasible to consider customizing medication therapy to improve outcomes in this patient population.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Barostim neo- Baroreflex Activation Therapy for Heart Failure Save

Date Added
May 26th, 2015
PRO Number
Pro00044328
Researcher
Adrian Van Bakel
Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to show whether the Barostim Neo system is safe and works in people with heart failure. The device is designed to stimulate the body's natural cardiovascular regulators in your neck to potentially improve your heart failure condition.

Institution
MUSC
Recruitment Contact
Mariann Schulz
843-876-5009
schulzmt@musc.edu

MOMENTUM 3: Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3™ Continued Access Protocol Save

Date Added
May 12th, 2015
PRO Number
Pro00043798
Researcher
Adrian Van Bakel
Keywords
Heart, Surgery
Summary

This study is comparing a newer left ventricular assist system called the HeartMate III to the currently available HeartMate II system in patients with advanced left ventricular heart failure. A left ventricular assist system is designed to provide hemodynamic support either for a short period of time, such as while waiting for a heart transplant, or for a longer period of time when other treatment options are not enough.

The purpose of this MOMENTUM 3 Continued Access Protocol (CAP) is to continue to collect data on the HeartMate 3 while the FDA is reviewing study results of the MOMENTUM 3 trial. The MOMENTUM 3 study has completed enrollment and the FDA is now reviewing safety and performance data.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

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