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)

Last updated: April 10, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

Non-mavacamten symptomatic oHCM therapy

Mavacamten

Clinical Study ID

NCT05489705
CV027-012
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 1600
Treatment Group(s): 2
Primary Treatment: Non-mavacamten symptomatic oHCM therapy
Phase:
Study Start date:
August 16, 2022
Estimated Completion Date:
August 17, 2029

Connect with a study center

  • Local Institution - 0082

    Braunau am Inn, 5280
    Austria

    Site Not Available

  • Local Institution - 0087

    Graz, 8036
    Austria

    Site Not Available

  • Local Institution - 0088

    Innsbruck, 6020
    Austria

    Site Not Available

  • Local Institution - 0084

    Klagenfurt am Worthersee, 9020
    Austria

    Site Not Available

  • Local Institution - 0086

    Linz, 4021
    Austria

    Site Not Available

  • Local Institution - 0085

    St. Pölten, 3100
    Austria

    Site Not Available

  • Local Institution - 0083

    Wien, 1090
    Austria

    Site Not Available

  • Centre Hospitalier Haguenau

    Haguenau, Bas Rhin 67500
    France

    Active - Recruiting

  • Local Institution - 0092

    Haguenau, Bas Rhin 67500
    France

    Site Not Available

  • Local Institution - 0093

    Saint-Herblain, Loire Atlantique 44800
    France

    Site Not Available

  • Local Institution - 0090

    Lille, Nord 59000
    France

    Site Not Available

  • Local Institution - 0091

    Amiens Cedex 1, Somme 80054
    France

    Site Not Available

  • Local Institution - 0094

    Toulon, Var 83000
    France

    Site Not Available

  • Local Institution - 0089

    Poitiers, Vienne 86000
    France

    Site Not Available

  • Local Institution - 0098

    Aalen, Baden Wuerttemberg 73430
    Germany

    Site Not Available

  • Local Institution - 0101

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Local Institution - 0095

    Bernau, Berlin 16321
    Germany

    Site Not Available

  • Local Institution - 0100

    Muenster, Nordrhein Westfalen 48149
    Germany

    Site Not Available

  • Local Institution - 0099

    Dresden, Sachsen 01099
    Germany

    Site Not Available

  • Local Institution - 0097

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Local Institution - 0096

    Berlin, 10719
    Germany

    Site Not Available

  • Local Institution - 0077

    Ponce, 00717-1322
    Puerto Rico

    Site Not Available

  • Research & Cardiovascular Corp

    Ponce, 00717-1322
    Puerto Rico

    Active - Recruiting

  • Local Institution - 0106

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Local Institution - 0109

    Palma De Mallorca, Baleares 07198
    Spain

    Site Not Available

  • Local Institution - 0104

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Local Institution - 0105

    El Palmar, Murcia 30120
    Spain

    Site Not Available

  • Local Institution - 0107

    Burgos, 09006
    Spain

    Site Not Available

  • Local Institution - 0102

    Madrid, 28007
    Spain

    Site Not Available

  • Local Institution - 0108

    Madrid, 28040
    Spain

    Site Not Available

  • Local Institution - 0103

    Malaga, 29010
    Spain

    Site Not Available

  • Local Institution - 0113

    London, Greater London SW3 6NP
    United Kingdom

    Site Not Available

  • Local Institution - 0115

    London, Greater London W6 8RF
    United Kingdom

    Site Not Available

  • Local Institution - 0112

    Manchester, Greater Manchester M13 9WL
    United Kingdom

    Site Not Available

  • Local Institution - 0111

    Liverpool, Merseyside L14 3PE
    United Kingdom

    Site Not Available

  • Local Institution - 0110

    Birmingham, West Midlands B15 2GW
    United Kingdom

    Site Not Available

  • Local Institution - 0114

    Leeds, West Yorkshire LS1 3EX
    United Kingdom

    Site Not Available

  • Local Institution - 0116

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Alaska Heart Institute

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Local Institution - 0074

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Mayo Clinic - Arizona

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Pima Heart and Vascular

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • UAMS

    Little Rock, Arkansas 72205-7199
    United States

    Active - Recruiting

  • UC San Diego School of Medicine

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Keck School of Medicine of USC-Usc

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Local Institution - 0020

    Los Angeles, California 90048
    United States

    Site Not Available

  • Local Institution - 0012

    Palo Alto, California 94304
    United States

    Site Not Available

  • Stanford Health Care Hospital & Clinics

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Eisenhower Medical Center.

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Local Institution - 0061

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Local Institution - 0060

    Sacramento, California 95817
    United States

    Site Not Available

  • University Of California San Francisco Medical Center

    San Francisco, California 94117
    United States

    Active - Recruiting

  • Local Institution - 0050

    Aurora, Colorado 48377
    United States

    Site Not Available

  • UC Denver, AMC

    Aurora, Colorado 48377
    United States

    Active - Recruiting

  • Hartford HealthCare

    Hartford, Connecticut 06106
    United States

    Active - Recruiting

  • Local Institution - 0081

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Local Institution - 0071

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Uf Health Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • University of Chicago Dept of Medicine

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Local Institution - 0079

    Kankakee, Illinois 60901
    United States

    Site Not Available

  • Franciscan Physician Network-Indiana Heart Physicians

    Indianapolis, Indiana 46237
    United States

    Active - Recruiting

  • Indiana. University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Local Institution - 0045

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University Of Kansas Medical Center & Medical Pavilion

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Local Institution - 0059

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • MedStar Health Research Institute

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • University Of Maryland, Ihv

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Harvard (Massachusetts General Hospital)

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Local Institution - 0014

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Spectrum Health Medical Group

    Grand Rapids, Michigan 49525
    United States

    Active - Recruiting

  • Local Institution - 0049

    Novi, Michigan 48377
    United States

    Site Not Available

  • Henry Ford Health System

    West Bloomfield, Michigan 48322
    United States

    Active - Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Cardiology Associates Research, Llc

    Tupelo, Mississippi 38801
    United States

    Active - Recruiting

  • Local Institution - 0069

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • St. Luke's Mid-America Heart Institute

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • CHI Health Reseach Center

    Omaha, Nebraska 68124
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0026

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Local Institution - 0078

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers- Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Bassett Medical Center

    Cooperstown, New York 13326
    United States

    Active - Recruiting

  • Northwell Health

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • Mount Sinai West

    New York, New York 10019
    United States

    Active - Recruiting

  • Saint Francis Hospital

    Roslyn, New York 11576
    United States

    Active - Recruiting

  • WMCHealth Advanced Physician Services

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Westchester Medical Center

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Focus Clinical Research

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Local Institution - 0072

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Duke University Health System

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Christ Hospital Health Network

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Local Institution - 0038

    Portland, Oregon 97239
    United States

    Site Not Available

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania 18015
    United States

    Active - Recruiting

  • Lancaster General Hospital

    Lancaster, Pennsylvania 17603
    United States

    Active - Recruiting

  • Local Institution - 0031

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • AHN

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Geisinger Health System

    Wilkes-Barre, Pennsylvania 18711
    United States

    Active - Recruiting

  • Local Institution - 0066

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Prisma Health - Upstate

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Local Institution - 0019

    Nashville, Tennessee 37205-2018
    United States

    Site Not Available

  • Saint Thomas Health

    Nashville, Tennessee 37205-2018
    United States

    Active - Recruiting

  • Tristar Centennial Medical Ctr

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Baylor Scott & White Research Institute

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • North Texas Cardiology Center

    Dallas, Texas 75208
    United States

    Active - Recruiting

  • BI Research Center

    Houston, Texas 77084
    United States

    Active - Recruiting

  • Baylor St. Luke's Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 0005

    Houston, Texas 77030
    United States

    Site Not Available

  • The Methodist Hospital, Methodist Cancer Cencer

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Baylor Scott & White The Heart Hospital Plano

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Local Institution - 0028

    Plano, Texas 75093
    United States

    Site Not Available

  • Baylor Scott & White Medical Centre - Temple

    Temple, Texas 76508
    United States

    Active - Recruiting

  • The Rector and Visitors of the Univ of Virginia

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Local Institution - 0064

    Norfolk, Virginia 23504
    United States

    Site Not Available

  • Sentara Healthcare

    Norfolk, Virginia 23504
    United States

    Site Not Available

  • VCU Medical Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Carilion Clinic; Virginia Tech-Carilion School of Medicine

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Local Institution - 0032

    Seattle, Washington 98195
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Active - Recruiting

  • WVU Hospitals

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • University Of Wisconsin - Madison

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • Local Institution - 0054

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin, Inc (PI Address)

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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