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.
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.
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.