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Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

RECRUITINGPhase 2Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 2
SponsorBristol-Myers Squibb
Started2023-11-07
Est. completion2026-07-03
Eligibility
Age40 Years – 85 Years
Healthy vol.Accepted
Locations31 sites
View on ClinicalTrials.gov →

NCT06122779

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: 40 Years – 85 YearsHealthy volunteers accepted
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.

Conditions2

Heart DiseaseHeart Failure

Interventions1

BMS-986435

Locations31 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35233
Pankaj Arora, Site 0002
Colorado Heart and Vascular - Lakewood
Lakewood, Colorado, 80228-1710
McHale Anderson, Site 0096303-595-2619
Ascension St. Vincent's Riverside Hospital - PPDS
Jacksonville, Florida, 32204-4748
Nima Taghipour, Site 0077888-888-8888
Local Institution - 0003
Miami, Florida, 33133-4223
University of Miami FL Miller School of Medicine -1120 NW 14th St
Miami, Florida, 33136-2107
Omar Wever-Pinzon, Site 0099

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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