A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)
Recruiting now
Conditions studied: Obstructive Hypertrophic Cardiomyopathy
In brief
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment. United States Sub-Study: The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Europe Sub-Study: The purpose of this study is to evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting.
Key facts
- Study ID
- NCT05489705
- Run by
- Bristol-Myers Squibb
- People needed
- 1700
- Starts
- 2022-08-16
- Expected to finish
- 2029-08-17
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 18 years of age at the time of informed consent.
- Willing and able to provide written informed consent form (ICF) and any required privacy authorization prior to the initiation of study procedures (or in those situations where consent cannot be given by participants, consent provided by their legally acceptable representatives)
- United States Sub-Study
- Diagnosis of obstructive HCM consistent with 2020 American Heart Association/American College of Cardiology (AHA/ACC) guidelines.
- Obstructive HCM is defined clinically by the presence of increased LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of HCM) in a nondilated ventricular chamber that is not solely explained by abnormal loading conditions (eg, another cardiac or systemic disease) and peak LVOT gradient of ≥ 30 mmHg at rest or with provocation.
- Has documented LVEF of ≥ 55% recorded by echocardiography within the last 6 months.
- Symptoms consistent with NYHA functional class II-IV.
- Receiving beta blocker (BB)s, non-dihydropyridine calcium. channel blockers (nonDHP CCBs), disopyramide, and/or mavacamten (once available) as part of routine clinical care; or currently receiving no treatment due to intolerance or failure of prior treatment (eg, BBs, non-DHP CCBs, or disopyramide) for obstructive HCM.
- European Sub-study
- Diagnosis of obstructive HCM consistent with the most recent European Society of Cardiology (ESC) and American Heart Association/American College of Cardiology (AHA/ACC) guidelines
- Documented LVEF of ≥55% recorded by TTE
- Documented symptoms consistent with NYHA functional class II-III at enrollment or within 6 months prior to enrollment (if not available at enrollment).
- As part of routine clinical care for obstructive HCM: receiving BBs, non-DHP CCBs, disopyramide; initiating mavacamten at enrollment; or currently receiving no treatment due to intolerance or failure of prior treatment (e.g., BBs, non-DHP CCBs, or disopyramide).
You may not qualify if…
- Known phenocopy disease (e.g., Fabry disease, amyloidosis) or LV hypertrophy associated with hypertension.
- Documentation of any fixed obstruction of the outflow tract such as aortic valve stenosis or replacement.
- Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to enrollment; participants with an unsuccessful myectomy or percutaneous ASA performed > 6 months prior to enrollment may be enrolled.
- Naïve to treatment for obstructive HCM (ie, never treated with BBs, nonDHP CCBs, or disopyramide).
- United States Sub-Study
- Receiving an investigational therapeutic agent for obstructive HCM (eg, myosin-inhibitors other than mavacamten) in an interventional clinical trial at participant enrollment.
- Previously or currently enrolled in a long-term safety extension study of mavacamten (eg, EXPLORER-HCM [ClinicalTrials.gov, NCT03470545], MAVA-LTE [NCT03723655], PIONEER-OLE [NCT03496168], VALORHCM [NCT04349072], or MAVERICK [NCT03442764])
- European Sub-study
- Receiving an investigational therapeutic agent or any cardiac myosin inhibitor and/or modulators for obstructive HCM at patient enrolment
- Previously or currently enrolled in other HCM registry studies (e.g., TORCH, REMY, EU-PASS)
- Previously or currently enrolled in a study of mavacamten (e.g., EXPLORER-HCM [ClinicalTrials.gov, NCT03470545], MAVA-LTE [NCT03723655], PIONEER-OLE [NCT03496168], VALOR-HCM [NCT04349072], MAVERICK [NCT03442764], or MEMENTO [NCT2264899])
- Previously treated with mavacamten
Where it is running
- Pima Heart and Vascular — Tucson, Arizona, United States (enrolling)
- UAMS — Little Rock, Arkansas, United States (enrolling)
- UC San Diego School of Medicine — La Jolla, California, United States (enrolling)
- Keck School of Medicine of USC-Usc — Los Angeles, California, United States (enrolling)
- Stanford Health Care Hospital & Clinics — Palo Alto, California, United States (enrolling)
- University Of California San Francisco Medical Center — San Francisco, California, United States (enrolling)
- UC Denver, AMC — Aurora, Colorado, United States (enrolling)
- Hartford HealthCare — Hartford, Connecticut, United States (enrolling)
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
- Uf Health Jacksonville — Jacksonville, Florida, United States (enrolling)
- University of Hawaii Cancer Center — Honolulu, Hawaii, United States (enrolling)
- University of Chicago Dept of Medicine — Chicago, Illinois, United States (enrolling)
- Indiana. University — Indianapolis, Indiana, United States (enrolling)
- Franciscan Physician Network-Indiana Heart Physicians — Indianapolis, Indiana, United States (enrolling)
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (enrolling)
- University Of Kansas Medical Center & Medical Pavilion — Kansas City, Kansas, United States (enrolling)
- University Of Maryland, Ihv — Baltimore, Maryland, United States (enrolling)
- MedStar Health Research Institute — Baltimore, Maryland, United States (enrolling)
- Harvard (Massachusetts General Hospital) — Boston, Massachusetts, United States (enrolling)
- Harvard Medical School - Brigham and Women's Hospital (BWH) — Boston, Massachusetts, United States (enrolling)
- Spectrum Health Medical Group — Grand Rapids, Michigan, United States (enrolling)
- Henry Ford Health System — West Bloomfield, Michigan, United States (enrolling)
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
- Cardiology Associates Research, Llc — Tupelo, Mississippi, United States (enrolling)
- Alaska Heart Institute — Anchorage, Alaska, United States (enrolling)
Full record on ClinicalTrials.gov
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