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

NCT06122779 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 2

Started

2023-11-07

Last updated

2026-07-30

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

BMS-986435Placebo

BMS-986435: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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

Sex

ALL

Min age

40 Years

Max age

85 Years

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of treatment emergent adverse events (TEAEs) — Up to approximately 24 weeks
Incidence of serious adverse events (SAEs) — Up to approximately 24 weeks
Incidence of AEs leading to treatment discontinuation — Up to approximately 20 weeks

Trial sites (86)

Facility	City	Region
Local Institution - 0002	Birmingham	Alabama
Local Institution - 0096	Lakewood	Colorado
Local Institution - 0077	Jacksonville	Florida
Local Institution - 0003	Miami	Florida
Local Institution - 0099	Miami	Florida
Local Institution - 0004	Chicago	Illinois
Local Institution - 0005	Hazel Crest	Illinois
Local Institution - 0029	Indianapolis	Indiana
Local Institution - 0028	St Louis	Missouri
Local Institution - 0117	Hackensack	New Jersey
Local Institution - 0070	Albany	New York
Local Institution - 0105	Brooklyn	New York
Local Institution - 0008	New York	New York
Local Institution - 0059	Rochester	New York
Local Institution - 0076	Rochester	New York
Local Institution - 0094	Rosedale	New York
Local Institution - 0095	Durham	North Carolina
Local Institution - 0016	Oklahoma City	Oklahoma
Local Institution - 0078	Abington	Pennsylvania
Local Institution - 0001	Tullahoma	Tennessee
Local Institution - 0104	Austin	Texas
Local Institution - 0036	Dallas	Texas
Local Institution - 0015	Houston	Texas
Local Institution - 0054	Ciudad del Libertador General San Martin	Buenos Aires
Local Institution - 0115	Zárate	Buenos Aires
Local Institution - 0090	Córdoba	Córdoba Province
Local Institution - 0053	Córdoba	Córdoba Province
Local Institution - 0073	Rosario	Santa Fe Province
Local Institution - 0061	San Miguel de Tucumán	Tucumán Province
Local Institution - 0060	Buenos Aires	Argentina
Local Institution - 0067	Buenos Aires	Argentina
Local Institution - 0074	Córdoba	Argentina
Local Institution - 0069	Salta	Argentina
Local Institution - 0102	Santa Fe	Argentina
Local Institution - 0007	Hamilton	Ontario
Local Institution - 0037	Toronto	Ontario
Local Institution - 0089	Beijing	Beijing Municipality
Local Institution - 0087	Guangzhou	Guangdong
Local Institution - 0080	Luoyang	Henan
Local Institution - 0079	Changsha	Hunan

+ 46 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06122779 on ClinicalTrials.gov ↗ ← All trials in the UK