A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria \- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability. Exclusion Criteria * Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant. * Other protocol-defined Inclusion/Exclusion criteria apply.
Interventions
- DrugBMS-986435
Specified dose on specified days
- OtherPlacebo
Specified dose on specified days
Locations (117)
- University of Alabama at BirminghamBirmingham, Alabama
- Colorado Heart and Vascular - LakewoodLakewood, Colorado
- Ascension St. Vincent's Riverside Hospital - PPDSJacksonville, Florida
- Local Institution - 0003Miami, Florida
- University of Miami FL Miller School of Medicine -1120 NW 14th StMiami, Florida
- Local Institution - 0014Atlanta, Georgia