Evaluating a new treatment for heart failure with preserved ejection fraction
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)
This study is testing a new drug to see if it can safely help adults with heart failure and preserved ejection fraction feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 117 sites (Birmingham, Alabama and 116 other locations) |
| Trial ID | NCT06122779 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of the drug BMS-986435/MYK-224 in adults with symptomatic heart failure with preserved ejection fraction (HFpEF). Participants will receive either the active drug or a placebo, and the study will monitor drug levels and the body's response to the treatment. The goal is to determine how well the drug is tolerated and its potential effectiveness in managing HFpEF symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults with stable, symptomatic heart failure with preserved ejection fraction and normal heart pumping ability.
Not a fit: Patients with obstructive or genetic hypertrophic cardiomyopathy, infiltrative/storage disorders, or other serious conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the management of heart failure with preserved ejection fraction, enhancing patients' quality of life.
How similar studies have performed: Other studies have explored treatments for heart failure, but the specific approach of this trial is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama and 116 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Colorado Heart and Vascular - Lakewood — Lakewood, Colorado, United States (Recruiting)
- Ascension St. Vincent's Riverside Hospital - PPDS — Jacksonville, Florida, United States (Recruiting)
- Local Institution - 0003 — Miami, Florida, United States (Active_not_recruiting)
- University of Miami FL Miller School of Medicine -1120 NW 14th St — Miami, Florida, United States (Recruiting)
- Local Institution - 0014 — Atlanta, Georgia, United States (Withdrawn)
- Local Institution - 0048 — Atlanta, Georgia, United States (Withdrawn)
- Bluhm Cardiovascular Institute of Northwestern — Chicago, Illinois, United States (Recruiting)
- Chicago Medical Research, LLC - Hazel Crest — Hazel Crest, Illinois, United States (Recruiting)
- Ascension Medical Group St. Vincent - Indianapolis Heart Care — Indianapolis, Indiana, United States (Recruiting)
- Local Institution - 0045 — Indianapolis, Indiana, United States (Withdrawn)
- St. Louis Heart and Vascular — St Louis, Missouri, United States (Recruiting)
- Local Institution - 0043 — St Louis, Missouri, United States (Withdrawn)
- Local Institution - 0117 — Hackensack, New Jersey, United States (Not_yet_recruiting)
- Capital Cardiology Associates — Albany, New York, United States (Recruiting)
- Local Institution - 0105 — Brooklyn, New York, United States (Not_yet_recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- University of Rochester Medical Center - PPDS — Rochester, New York, United States (Recruiting)
- Rochester General Hospital Center for Clinical Research — Rochester, New York, United States (Recruiting)
- Laurelton Heart Specialist PC - MyClinical - PPDS — Rosedale, New York, United States (Recruiting)
- Duke Cardiology Clinic - PPDS — Durham, North Carolina, United States (Recruiting)
- Local Institution - 0058 — Cincinnati, Ohio, United States (Withdrawn)
- Local Institution - 0041 — Oklahoma City, Oklahoma, United States (Withdrawn)
- South Oklahoma Heart Research — Oklahoma City, Oklahoma, United States (Recruiting)
- Abington Memorial Hospital — Abington, Pennsylvania, United States (Recruiting)
- Tennessee Center for Clinical Trials — Tullahoma, Tennessee, United States (Recruiting)
- Local Institution - 0104 — Austin, Texas, United States (Not_yet_recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Angiocardiac Care of Texas - PA - PPDS — Houston, Texas, United States (Recruiting)
- Local Institution - 0051 — Houston, Texas, United States (Withdrawn)
- Local Institution - 0066 — Falls Church, Virginia, United States (Withdrawn)
- Corporación Médica de General San Martín — Ciudad del Libertador General San Martin, Buenos Aires, Argentina (Recruiting)
- Local Institution - 0107 — Zárate, Buenos Aires, Argentina (Withdrawn)
- Local Institution - 0115 — Zárate, Buenos Aires, Argentina (Not_yet_recruiting)
- Local Institution - 0090 — Córdoba, Córdoba Province, Argentina (Not_yet_recruiting)
- Local Institution - 0053 — Córdoba, Córdoba Province, Argentina (Not_yet_recruiting)
- Local Institution - 0073 — Rosario, Santa Fe Province, Argentina (Not_yet_recruiting)
- IPR-Investigaciones en Patologías Respiratorias — San Miguel de Tucumán, Tucumán Province, Argentina (Recruiting)
- Centro de Especialidades Médicas CEMEDIC — Buenos Aires, Argentina (Recruiting)
- Local Institution - 0068 — Buenos Aires, Argentina (Withdrawn)
- Local Institution - 0067 — Buenos Aires, Argentina (Not_yet_recruiting)
- Sanatorio Duarte Quirós — Córdoba, Argentina (Recruiting)
- Local Institution - 0069 — Salta, Argentina (Not_yet_recruiting)
- Centro de Investigaciones Clínicas Del Litoral SRL — Santa Fe, Argentina (Recruiting)
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
- Medicus MFC Inc. — Toronto, Ontario, Canada (Recruiting)
- Local Institution - 0030 — Toronto, Ontario, Canada (Withdrawn)
- Local Institution - 0040 — Toronto, Ontario, Canada (Withdrawn)
- Local Institution - 0011 — Montreal, Quebec, Canada (Withdrawn)
- Local Institution - 0035 — Trois-Rivières, Quebec, Canada (Withdrawn)
+67 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.