RecruitingPhase 2

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

United States208 participantsStarted 2023-11-07

Plain-language 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).

Who can participate

Age range40 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of treatment emergent adverse events (TEAEs)

Timeframe: Up to approximately 24 weeks

Incidence of serious adverse events (SAEs)

Timeframe: Up to approximately 24 weeks

Incidence of AEs leading to treatment discontinuation

Timeframe: Up to approximately 20 weeks

Trial details

NCT IDNCT06122779

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-03

Contact for this trial

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

View on ClinicalTrials.gov More Heart Failure trials