Status:
RECRUITING
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Heart Failure
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief 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 (HF...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 3 2026
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06122779
Start Date
November 7 2023
End Date
July 3 2026
Last Update
December 15 2025
Active Locations (117)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Colorado Heart and Vascular - Lakewood
Lakewood, Colorado, United States, 80228-1710
3
Ascension St. Vincent's Riverside Hospital - PPDS
Jacksonville, Florida, United States, 32204-4748
4
Local Institution - 0003
Miami, Florida, United States, 33133-4223