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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)

Sponsored by Bristol-Myers Squibb

About this 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.

Where this study is enrolling (39)

  • Alaska Heart Institute

    Anchorage, Alaska

    Call 907-561-3211

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  • Pima Heart and Vascular

    Tucson, Arizona

    Call 520-838-3540

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  • UAMS

    Little Rock, Arkansas

    Call 501-686-5545

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  • Keck School of Medicine of USC-Usc

    Los Angeles, California

    Call 323-442-6130

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  • UC Denver, AMC

    Aurora, Colorado

    Call 720-848-5300

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Show all 39 locations

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia

    Call 202-877-5975

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  • University of Chicago Dept of Medicine

    Chicago, Illinois

    Call 773-702-1234

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  • Indiana. University

    Indianapolis, Indiana

    Call 317-962-9700

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  • Franciscan Physician Network-Indiana Heart Physicians

    Indianapolis, Indiana

    Call 317-893-1712

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  • Harvard Medical School - Brigham and Women's Hospital (BWH)

    Boston, Massachusetts

    Call 617-732-5500

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  • Harvard (Massachusetts General Hospital)

    Boston, Massachusetts

    Call 617-724-5434

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  • Spectrum Health Medical Group

    Grand Rapids, Michigan

    Call 616-885-5000

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  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota

    Call 612-863-3900

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  • Cardiology Associates Research, Llc

    Tupelo, Mississippi

    Call 904-392-2469

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  • Washington University

    St Louis, Missouri

    Call 314-362-1963

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  • Hackensack University Medical Center

    Hackensack, New Jersey

    Call 551-996-5870

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  • Mount Sinai Hospital

    New York, New York

    Call 917-751-5850

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  • WMCHealth Advanced Physician Services

    Valhalla, New York

    Call 914-598-7651

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  • Bassett Medical Center

    Cooperstown, New York

    Call 607-547-4582

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  • Saint Francis Hospital

    Roslyn, New York

    Call 631-707-2586

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  • Focus Clinical Research

    Charlotte, North Carolina

    Call 888-635-0552

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  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio

    Call 216-286-1023

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  • Christ Hospital Health Network

    Cincinnati, Ohio

    Call 513-721-8881

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  • St. Luke's University Health Network

    Bethlehem, Pennsylvania

    Call 718-430-3314

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  • Geisinger Health System

    Wilkes-Barre, Pennsylvania

    Call 570-808-6020

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  • Prisma Health - Upstate

    Greenville, South Carolina

    Call 864-455-7727

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  • Tristar Centennial Medical Ctr

    Nashville, Tennessee

    Call 347-949-3060

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  • Saint Thomas Health

    Nashville, Tennessee

    Call 615-269-4545

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  • North Texas Cardiology Center

    Dallas, Texas

    Call 214-933-7430

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  • The Methodist Hospital, Methodist Cancer Cencer

    Houston, Texas

    I'm interested

  • BI Research Center

    Houston, Texas

    I'm interested

  • Baylor Scott & White The Heart Hospital Plano

    Plano, Texas

    Call 469-800-6390

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  • Baylor Scott & White Medical Centre - Temple

    Temple, Texas

    Call 254-724-5119

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  • Carilion Clinic; Virginia Tech-Carilion School of Medicine

    Roanoke, Virginia

    Call 540-982-8204

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  • The Rector and Visitors of the Univ of Virginia

    Charlottesville, Virginia

    Call 434-982-0853

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  • VCU Medical Center

    Richmond, Virginia

    Call 804-828-9989

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  • Virginia Mason Medical Center

    Seattle, Washington

    Call 206-341-1111

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  • WVU Hospitals

    Morgantown, West Virginia

    Call 304-598-4000

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  • Medical College of Wisconsin, Inc (PI Address)

    Milwaukee, Wisconsin

    Call 414-805-6000

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.