Evaluating the effects of Mavacamten on heart structure in patients with obstructive hypertrophic cardiomyopathy
MEMENTO - A Phase 4, Single-arm, Open-label Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy to Assess the Impact on Myocardial Structure With Cardiac Magnetic Resonance Imaging (CMR)
This study is testing if a medication called Mavacamten can improve heart structure in adults with obstructive hypertrophic cardiomyopathy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 89 sites (Los Angeles, California and 88 other locations) |
| Trial ID | NCT06112743 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of Mavacamten on myocardial structure in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Participants will undergo cardiac magnetic resonance imaging (CMR) to evaluate changes in heart structure. Eligible candidates must have specific functional class symptoms and measurable cardiac parameters as defined by established guidelines. The study is interventional and is classified as Phase 4.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic obstructive hypertrophic cardiomyopathy who meet specific cardiac function criteria.
Not a fit: Patients with other cardiac conditions that mimic obstructive hypertrophic cardiomyopathy or those with significant coronary artery disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with obstructive hypertrophic cardiomyopathy.
How similar studies have performed: Previous studies have shown promise in using Mavacamten for treating obstructive hypertrophic cardiomyopathy, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:. * Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise. * Left ventricular ejection fraction (LVEF) ≥ 55% at rest. * New York Heart Association (NYHA) functional class II or III symptoms. Exclusion Criteria * A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM. * Documented obstructive coronary artery disease or history of myocardial infarction. * A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening. * An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR). * Other protocol-defined inclusion/exclusion criteria apply.
Where this trial is running
Los Angeles, California and 88 other locations
- Cedars Sinai Medical Center - 1207 San Vicente Blvd — Los Angeles, California, United States (Recruiting)
- Piedmont Hospital — Atlanta, Georgia, United States (Recruiting)
- Local Institution - 0091 — Honolulu, Hawaii, United States (Withdrawn)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University Hospitals Cleveland Medical Center - 11100 Euclid Ave — Cleveland, Ohio, United States (Recruiting)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
- Local Institution - 0035 — Murray, Utah, United States (Active_not_recruiting)
- Fundación Favaloro - Avenida Belgrano 1746 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (Recruiting)
- Local Institution - 0075 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (Not_yet_recruiting)
- Local Institution - 0079 — Pilar, Buenos Aires, Argentina (Not_yet_recruiting)
- Sanatorio Allende S.A.-Pedro Simón Laplace 5749 — Córdoba, Cordoba, Argentina (Recruiting)
- Hospital Privado de Rosario — Rosario, Santa FE, Argentina (Recruiting)
- Hospital Italiano de Buenos Aires — Ciudad Autonoma de Buenos Aires, Argentina (Recruiting)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
- Local Institution - 0082 — Darlinghurst, New South Wales, Australia (Withdrawn)
- Prince Charles Hospital — Chermside, Queensland, Australia (Recruiting)
- Local Institution - 0022 — Herston, Queensland, Australia (Withdrawn)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Local Institution - 0057 — Klagenfurt am Wörthersee, Kärnten, Austria (Withdrawn)
- Local Institution - 0032 — Braunau am Inn, Upper Austria, Austria (Withdrawn)
- Local Institution - 0028 — Graz, Austria (Withdrawn)
- Local Institution - 0088 — Wien, Austria (Withdrawn)
- Local Institution - 0007 — Wien, Austria (Withdrawn)
- Local Institution - 0084 — Anderlecht, Brussels, Belgium (Withdrawn)
- Local Institution - 0070 — Bruxelles, Brussels, Belgium (Withdrawn)
- Local Institution - 0069 — Jette, Brussels, Belgium (Withdrawn)
- Local Institution - 0092 — Genk, Limburg, Belgium (Withdrawn)
- Local Institution - 0083 — Leuven, Vlaams Brabant, Belgium (Withdrawn)
- Local Institution - 0071 — Roeselare, West-Vlaanderen, Belgium (Withdrawn)
- Local Institution - 0004 — Calgary, Alberta, Canada (Withdrawn)
- Institut de Cardiologie de Montreal — Montreal, Quebec, Canada (Recruiting)
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval — Quebec, Canada (Recruiting)
- Local Institution - 0016 — Broumov, Královéhradecký Kraj, Czechia (Withdrawn)
- Local Institution - 0053 — Trinec, Moravskoslezský Kraj, Czechia (Withdrawn)
- Local Institution - 0050 — Prague, Praha, Hlavní Mesto, Czechia (Withdrawn)
- Local Institution - 0011 — Praha 2, Praha, Hlavní Mesto, Czechia (Withdrawn)
- Local Institution - 0052 — Brno, Czechia (Withdrawn)
- Local Institution - 0073 — Helsinki, Etelä-Suomen Lääni, Finland (Withdrawn)
- Local Institution - 0072 — Turku, Länsi-Suomen Lääni, Finland (Withdrawn)
- Local Institution - 0031 — Grenoble, France (Withdrawn)
- Local Institution - 0014 — Paris, France (Withdrawn)
- Local Institution - 0026 — Pessac, France (Withdrawn)
- Local Institution - 0002 — Rennes, France (Withdrawn)
- Local Institution - 0047 — Giessen, Hessen, Germany (Withdrawn)
- Local Institution - 0034 — Göttingen, Niedersachsen, Germany (Withdrawn)
- Local Institution - 0040 — Bad Oeynhausen, Nordrhein-Westfalen, Germany (Withdrawn)
- Local Institution - 0023 — Berlin, Germany (Withdrawn)
- Local Institution - 0009 — Athina, Attiki, Greece (Withdrawn)
- Local Institution - 0008 — Athina, Attiki, Greece (Withdrawn)
+39 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.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.