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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)

RecruitingObservational study

Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States and European Prospective Registry Study

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria

* ≥ 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).

Exclusion Criteria

* 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

About the study

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.

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 1,700 · Started: Aug 16, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05489705

Locations in the U.S.

AlaskaAlaska Heart Institute, Anchorage
ArizonaPima Heart and Vascular, Tucson
ArkansasUAMS, Little Rock
CaliforniaKeck School of Medicine of USC-Usc, Los Angeles
Stanford Health Care Hospital & Clinics, Palo Alto
University Of California San Francisco Medical Center, San Francisco
ColoradoUC Denver, AMC, Aurora
District of ColumbiaMedStar Washington Hospital Center, Washington D.C.
IllinoisUniversity of Chicago Dept of Medicine, Chicago
IndianaFranciscan Physician Network-Indiana Heart Physicians, Indianapolis
Indiana. University, Indianapolis
MarylandMedStar Health Research Institute, Baltimore
MassachusettsHarvard (Massachusetts General Hospital), Boston
Harvard Medical School - Brigham and Women's Hospital (BWH), Boston
MichiganSpectrum Health Medical Group, Grand Rapids
Henry Ford Health System, West Bloomfield
MinnesotaMinneapolis Heart Institute Foundation, Minneapolis
MississippiCardiology Associates Research, Llc, Tupelo
MissouriSt. Luke's Mid-America Heart Institute, Kansas City
Washington University, St Louis
NebraskaCHI Health Reseach Center, Omaha
New JerseyHackensack University Medical Center, Hackensack
New YorkBassett Medical Center, Cooperstown
Mount Sinai Hospital, New York
Saint Francis Hospital, Roslyn
WMCHealth Advanced Physician Services, Valhalla
North CarolinaFocus Clinical Research, Charlotte
Duke University Health System, Durham
OhioChrist Hospital Health Network, Cincinnati
University Hospitals Cleveland Medical Center, Cleveland
PennsylvaniaSt. Luke's University Health Network, Bethlehem
University Of Pittsburgh, Pittsburgh
Geisinger Health System, Wilkes-Barre
South CarolinaPrisma Health - Upstate, Greenville
TennesseeSaint Thomas Health, Nashville
Tristar Centennial Medical Ctr, Nashville
TexasBaylor Scott & White Research Institute, Dallas
North Texas Cardiology Center, Dallas
BI Research Center, Houston
The Methodist Hospital, Methodist Cancer Cencer, Houston
Baylor Scott & White The Heart Hospital Plano, Plano
Baylor Scott & White Medical Centre - Temple, Temple
VirginiaThe Rector and Visitors of the Univ of Virginia, Charlottesville
VCU Medical Center, Richmond
Carilion Clinic; Virginia Tech-Carilion School of Medicine, Roanoke
WashingtonVirginia Mason Medical Center, Seattle
West VirginiaWVU Hospitals, Morgantown
WisconsinMedical College of Wisconsin, Inc (PI Address), Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.