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) (DISCOVER-HCM)

June 11, 2026 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Austria
      • Braunau am Inn, Austria, 5280
        • Recruiting
        • KH St.Josef Braunau am Inn
        • Contact:
          • Johann Auer, Site 0082
          • Phone Number: +437722804510
      • Graz, Austria, 8036
        • Recruiting
        • LKH-Univ. Klinikum Graz
        • Contact:
          • Nicolas Verheyen, Site 0087
          • Phone Number: +433163851254
      • Innsbruck, Austria, 6020
        • Not yet recruiting
        • Local Institution - 0088
        • Contact:
          • Site 0088
      • Klagenfurt, Austria, 9020
        • Withdrawn
        • Local Institution - 0084
      • Linz, Austria, 4021
        • Recruiting
        • Kepler Universitätsklinikum Linz
        • Contact:
          • Christian Reiter, Site 0086
          • Phone Number: 4357680836220
      • Sankt Pölten, Austria, 3100
        • Not yet recruiting
        • Local Institution - 0085
        • Contact:
          • Site 0085
      • Vienna, Austria, 1090
        • Not yet recruiting
        • Local Institution - 0083
        • Contact:
          • Site 0083
  • France
      • Montpellier, France, 34000
        • Withdrawn
        • Local Institution - 0117
    • Bas Rhin
      • Haguenau, Bas Rhin, France, 67500
        • Recruiting
        • Centre Hospitalier Haguenau
        • Contact:
          • Charlotte Dagrenat, Site 0092
          • Phone Number: 33388063435
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44800
        • Recruiting
        • CHU Nantes Hopital Nord Laennec
        • Contact:
          • Nicolas Piriou, Site 0093
          • Phone Number: +33240165716
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • Hôpital Saint Vincent-de-Paul
        • Contact:
          • Ludovic Appert, Site 0090
          • Phone Number: 33320874996
    • Somme
      • Amiens, Somme, France, 80054
        • Recruiting
        • CHU AMIENS-PICARDIE
        • Contact:
          • Yohann Bohbot, Site 0091
          • Phone Number: 33322087258
    • Var
      • Toulon, Var, France, 83000
        • Recruiting
        • Hôpital Sainte Musse
        • Contact:
          • Jean-Michel Tartière, Site 0094
          • Phone Number: 33483772070
    • Vienne
      • Poitiers, Vienne, France, 86000
        • Recruiting
        • CHU De Poitiers - Hopital De La Miletrie
        • Contact:
          • Benjamin Alos, Site 0089
          • Phone Number: 33549444444
  • Germany
      • Berlin, Germany, 10719
        • Recruiting
        • Kardiologische und angiologische Praxen im Spreebogen
        • Contact:
          • Wilhelm Haverkamp, Site 0096
          • Phone Number: +4930450565906
    • Baden-Wurttemberg
      • Aalen, Baden-Wurttemberg, Germany, 73430
        • Recruiting
        • Ostalb-Klinikum Aalen
        • Contact:
          • Stephanie Loebig, Site 0098
          • Phone Number: 497361550
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Withdrawn
        • Local Institution - 0101
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitatsklinikum Muenster
        • Contact:
          • Jürgen Sindermann, Site 0100
          • Phone Number: +492518347426
    • Saxony
      • Dresden, Saxony, Germany, 01099
        • Recruiting
        • Praxisklinik Herz Und Gefasse-Klinikum Weisser Hirsch
        • Contact:
          • Gregor Simonis, Site 0099
          • Phone Number: 493518064440
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig Aoer
        • Contact:
          • Karsten Lenk, Site 0097
          • Phone Number: +4936419324521000000
    • State of Berlin
      • Bernau, State of Berlin, Germany, 16321
        • Recruiting
        • Immanuel Klinikum Bernau
        • Contact:
          • Christian Butter, Site 0095
          • Phone Number: +493338694644
  • Puerto Rico
      • Ponce, Puerto Rico, 00717-1322
        • Recruiting
        • Research & Cardiovascular Corp
        • Contact:
          • Jose Vazquez-Tanus, Site 0077
          • Phone Number: 7872908585
  • Spain
      • Burgos, Spain, 09006
        • Recruiting
        • Hospital Universitario de Burgos
        • Contact:
          • Ana Merino Merino, Site 0107
          • Phone Number: +34947281800
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Maria Alejandra Restrepo Cordoba, Site 0108
          • Phone Number: +34913303944
      • Madrid, Spain, 28007
        • Withdrawn
        • Local Institution - 0102
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Clinico Universitario Virgen de La Victoria
        • Contact:
          • José Manuel García Pinilla, Site 0103
          • Phone Number: +34951032349
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07198
        • Recruiting
        • Hospital Fundacion Son Llatzer
        • Contact:
          • Tomas Ripoll, Site 0109
          • Phone Number: +34871202102
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
          • Pablo García Pavia, Site 0104
          • Phone Number: +34911917297
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de La Arrixaca
        • Contact:
          • Juan Ramon Gimeno Blanes, Site 0105
          • Phone Number: +34619068153
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Rebeca Lorca Gutierrez, Site 0106
          • Phone Number: +3498510800033114
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales
        • Contact:
          • Zaheer Yousef, Site 0116
          • Phone Number: +442920716008
    • Greater London
      • London, Greater London, United Kingdom, W6 8RF
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
          • Amanda Varnava, Site 0115
          • Phone Number: +447532199693
      • London, Greater London, United Kingdom, SW3 6NP
        • Not yet recruiting
        • Local Institution - 0113
        • Contact:
          • Site 0113
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Recruiting
        • University Of Manchester
        • Contact:
          • Andrew Crean, Site 0112
          • Phone Number: +441612761234
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L14 3PE
        • Recruiting
        • Liverpool Heart and Chest Hospital
        • Contact:
          • Robert Cooper, Site 0111
          • Phone Number: +441512281616
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
          • William Bradlow, Site 0110
          • Phone Number: +441213714448
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds General Infirmary
        • Contact:
          • Alex Simms, Site 0114
          • Phone Number: +441133922385
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Heart Institute
        • Contact:
          • Ahmed Abuzaid, Site 0023
          • Phone Number: 907-561-3211
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Pima Heart and Vascular
        • Contact:
          • Greg Koshkarian, Site 0025
          • Phone Number: 000-000-0000
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-7199
        • Recruiting
        • UAMS
        • Contact:
          • Srikanth Vallurupalli, Site 0007
          • Phone Number: 501-686-5545
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego School of Medicine
        • Contact:
          • Jorge Silva Enciso, Site 0037
          • Phone Number: 858-246-2969
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck School of Medicine of USC-Usc
        • Contact:
          • Eugene DePasquale, Site 0057
          • Phone Number: 323-442-6130
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Health Care Hospital & Clinics
        • Contact:
          • Matthew Wheeler, Site 0012
      • San Francisco, California, United States, 94117
        • Recruiting
        • University Of California San Francisco Medical Center
        • Contact:
          • Theodore Abraham, Site 0021
    • Colorado
      • Aurora, Colorado, United States, 48377
        • Recruiting
        • UC Denver, AMC
        • Contact:
          • David Raymer, Site 0050
          • Phone Number: 720-848-5300
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Hartford HealthCare
        • Contact:
          • Adaya Weissler-Snir, Site 0067
          • Phone Number: 860-972-1506
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
          • Patrick Bering, Site 0081
          • Phone Number: 202-877-5975
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • Uf Health Jacksonville
        • Contact:
          • Andres Pineda, Site 0065
          • Phone Number: 904-244-5371
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • University of Hawaii Cancer Center
        • Contact:
          • Dipanjan Banerjee, Site 0046
          • Phone Number: 650-533-2433
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Dept of Medicine
        • Contact:
          • Gene Kim, Site 0063
          • Phone Number: 773-702-9396
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Franciscan Physician Network-Indiana Heart Physicians
        • Contact:
          • George Lolay, Site 0016
          • Phone Number: 317-893-1712
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana. University
        • Contact:
          • Roopa Rao, Site 0013
          • Phone Number: 317-962-9700
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals & Clinics
        • Contact:
          • Ernesto Ruiz Duque, Site 0045
          • Phone Number: 000-000-0000
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University Of Kansas Medical Center & Medical Pavilion
        • Contact:
          • Loren Berenbom, Site 0033
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • MedStar Health Research Institute
        • Contact:
          • Sandeep Jani, Site 0030
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University Of Maryland, Ihv
        • Contact:
          • Manjula Ananthram, Site 0059
          • Phone Number: 402-559-9800
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Harvard (Massachusetts General Hospital)
        • Contact:
          • Albree Tower-Rader, Site 0024
          • Phone Number: 617-724-5434
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Harvard Medical School - Brigham and Women's Hospital (BWH)
        • Contact:
          • Carolyn Ho, Site 0068
          • Phone Number: 617-732-5500
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Recruiting
        • Spectrum Health Medical Group
        • Contact:
          • David Fermin, Site 0073
          • Phone Number: 616-885-5000
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford Health System
        • Contact:
          • Karthikeyan Ananthasubramaniam, Site 0034
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Contact:
          • Robert Fraser, Site 0010
          • Phone Number: 612-863-3900
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • Cardiology Associates Research, Llc
        • Contact:
          • Barry Bertolet, Site 0062
          • Phone Number: 904-392-2469
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • St. Luke's Mid-America Heart Institute
        • Contact:
          • Michael Nassif, Site 0069
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
          • Richard Bach, Site 0036
          • Phone Number: 314-362-1963
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • CHI Health Reseach Center
        • Contact:
          • Amjad Kabach, Site 0070
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
          • Dmitry Nemirovsky, Site 0029
          • Phone Number: 551-996-5870
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Contact:
          • Matthew Martinez, Site 0026
          • Phone Number: 610-402-3110
    • New York
      • Cooperstown, New York, United States, 13326
        • Recruiting
        • Bassett Medical Center
        • Contact:
          • Mun Hong, Site 0006
          • Phone Number: 607-547-4582
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
          • Ronald Wharton, Site 0001
          • Phone Number: 516-562-3317
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Johanna Contreras, Site 0035
          • Phone Number: 917-751-5850
      • New York, New York, United States, 10019
        • Recruiting
        • Mount Sinai West
        • Contact:
          • Kim Kim, Site 0009
          • Phone Number: 212-492-5550
      • Roslyn, New York, United States, 11576
        • Recruiting
        • Saint Francis Hospital
        • Contact:
          • Allen Jeremias, Site 0075
          • Phone Number: 631-707-2586
      • Valhalla, New York, United States, 10595
        • Recruiting
        • WMCHealth Advanced Physician Services
        • Contact:
          • Srihari Naidu, Site 0053
          • Phone Number: 914-598-7651
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Focus Clinical Research
        • Contact:
          • Aamer Qurehshi, Site 0040
          • Phone Number: 888-635-0552
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Health System
        • Contact:
          • Andrew Wang, Site 0022
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Christ Hospital Health Network
        • Contact:
          • Wojciech Mazur, Site 0015
          • Phone Number: 513-721-8881
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
          • Anene Clair Ukaigwe, Site 0041
          • Phone Number: 216-286-1023
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Milind Desai, Site 0003
          • Phone Number: 216-445-5250
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's University Health Network
        • Contact:
          • Jamshid Shirani, Site 0043
          • Phone Number: 718-430-3314
      • Lancaster, Pennsylvania, United States, 17603
        • Recruiting
        • Lancaster General Hospital
        • Contact:
          • Robert Donovan, Site 0076
          • Phone Number: 412-613-7238
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh
        • Contact:
          • Timothy Wong, Site 0027
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • AHN Allegheny General Hospital
        • Contact:
          • Craig Alpert, Site 0002
          • Phone Number: 412-359-6739
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Health System
        • Contact:
          • Vernon Mascarenhas, Site 0056
          • Phone Number: 570-808-6020
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health - Upstate
        • Contact:
          • Josh Doll, Site 0042
          • Phone Number: 864-455-7727
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tristar Centennial Medical Ctr
        • Contact:
          • Bryan Doherty, Site 0048
          • Phone Number: 347-949-3060
      • Nashville, Tennessee, United States, 37205-2018
        • Recruiting
        • Saint Thomas Health
        • Contact:
          • Mark Zenker, Site 0019
          • Phone Number: 615-269-4545
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott & White Research Institute
        • Contact:
          • Robert Gottlieb, Site 0008
      • Dallas, Texas, United States, 75208
        • Recruiting
        • North Texas Cardiology Center
        • Contact:
          • Manavjot Sidhu, Site 0018
          • Phone Number: 214-933-7430
      • Houston, Texas, United States, 77084
        • Recruiting
        • BI Research Center
        • Contact:
          • Asif Akhtar, Site 0039
          • Phone Number: 281-944-3610
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital, Methodist Cancer Cencer
        • Contact:
          • Sherif Nagueh, Site 0058
          • Phone Number: 713-441-2850
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White The Heart Hospital Plano
        • Contact:
          • David Rawitscher, Site 0028
          • Phone Number: 469-800-6390
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Medical Centre - Temple
        • Contact:
          • Vinh Nguyen, Site 0051
          • Phone Number: 254-724-5119
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • The Rector and Visitors of the Univ of Virginia
        • Contact:
          • Christopher Kramer, Site 0011
          • Phone Number: 434-982-0853
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Medical Center
        • Contact:
          • Mohammed Makkiya, Site 0080
          • Phone Number: 804-828-9989
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Clinic; Virginia Tech-Carilion School of Medicine
        • Contact:
          • Ali Hama Amin, Site 0044
          • Phone Number: 540-982-8204
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Center
        • Contact:
          • Mariko Harper, Site 0052
          • Phone Number: 206-341-1111
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • WVU Hospitals
        • Contact:
          • Christopher Bianco, Site 0055
          • Phone Number: 304-598-4000
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University Of Wisconsin - Madison
        • Contact:
          • Ravi Dhingra, Site 0004
          • Phone Number: 608-265-1918
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin, Inc (PI Address)
        • Contact:
          • Abhinav Sharma, Site 0054
          • Phone Number: 414-805-6000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include adult participants with symptomatic obstructive HCM who are receiving pharmacological treatment for obstructive HCM (for example, BBs, non-DHP CCBs, disopyramide, and/or mavacamten) as part of routine care in the United States or Europe.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Mavacamten
Participants will receive mavacamten as prescribed by a physician according to standard of care for symptomatic oHCM
Drug: Mavacamten
As per product label
Beta-blocker (BB) / non-dihydropyridine (non-DHP) calcium channel blocker (CCB) / disopyramide
Participants will receive BB/non-DHP CCB/disopyramide as prescribed by a physician according to standard of care for symptomatic oHCM
Drug: Non-mavacamten symptomatic oHCM therapy
Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence rate of new or worsening heart failure due to systolic dysfunction among participants with symptomatic obstructive HCM during periods of exposure to mavacamten and other oHCM treatment
Time Frame: Up to 5 Years
Systolic dysfunction defined as symptomatic Left Ventricular Ejection Fraction (LVEF) < 50%. United States participants only.
Up to 5 Years
Change in resting left ventricular outflow tract (LVOT) gradient from baseline
Time Frame: Up to 18 months
European Participants only
Up to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of arrhythmia
Time Frame: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Incidence rates of participants with arrhythmia (new onset)
Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
New or worsening heart failure due to systolic dysfunction
Time Frame: Baseline and up to 18 months
Symptomatic left ventricular ejection fraction (LVEF) <50%. European Participants only
Baseline and up to 18 months
Proportion of participants with a resting or provoked peak left ventricular outflow tract (LVOT) gradient below 50 mmHG
Time Frame: Baseline and up to 18 months
European participants only
Baseline and up to 18 months
Proportion of participants with a resting or provoked peak left ventricular outflow tract (LVOT) gradient below 30 mmHG
Time Frame: Baseline and up to 18 months
European participants only
Baseline and up to 18 months
Occurrence of Major Adverse Cardiovascular Events (MACE)
Time Frame: Up to 5 Years
A composite endpoint consisting of non-fatal acute Myocardial Infarction (MI), stroke, hospitalization due to Heart Failure (HF) and Cardiovascular (CV) mortality. United States participants only.
Up to 5 Years
Occurrence of non-fatal acute Myocardial Infarction (MI)
Time Frame: Up to 5 Years
United States participants only
Up to 5 Years
Occurrence of Stroke
Time Frame: Up to 5 Years
United States participants only
Up to 5 Years
Occurrence of hospitalization due to heart failure
Time Frame: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Occurrence of cardiovascular mortality
Time Frame: Up to 5 Years
United States participants only
Up to 5 Years
Occurrence of all-cause mortality
Time Frame: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Evaluation of functional responses: New York Heart Association (NYHA) function class
Time Frame: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Percentage of Participants Whose NYHA Class Changes
Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Evaluation of functional responses: Left Ventricular Outflow Tract (LVOT) gradient
Time Frame: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Mean Change From Baseline in LVOT Gradients At Rest and Provoked
Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Evaluation of functional responses: LVEF
Time Frame: Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Mean Change from Baseline in LVEF
Baseline, and up to 18 months (European participants), or 5 Years (United States participants)
Evaluation of patient reported outcome measure: Kansas City Cardiomyopathy Questionnaire 23 (KCCQ-23)
Time Frame: Baseline, and up to 5 Years
The KCCQ-23 is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. United States participants only
Baseline, and up to 5 Years
Evaluation of patient reported outcome measure: EuroQol Five Dimensions Questionnaire (5-level) (EQ-5D-5L): Health Utility Index
Time Frame: Baseline, and up to 5 Years
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L health utility index and EQ Visual Analog Scale (VAS). EQ-5D-5L health utility index is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participants select an answer for each of the 5 dimensions that best matches his/her health "today". Responses are used to generate a weighted summary index, which ranges from 0 to 1.00. A higher score indicates better health and positive changes from baseline indicate improvement of health. United States participants only
Baseline, and up to 5 Years
Evaluation of patient reported outcome measure: EQ-5D-5L: VAS
Time Frame: Baseline, and up to 5 Years

The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and VAS.

The VAS self-rating records the participant's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status. United States participants only
Baseline, and up to 5 Years
Evaluation of biomarkers of response: NT-proBNP
Time Frame: Baseline, and up to 5 Years
Change From Baseline in Serum concentration of NT-proBNP. United States participants only
Baseline, and up to 5 Years
Evaluation of biomarkers of response: Cardiac troponin
Time Frame: Baseline, and up to 5 Years
Change From Baseline in Serum Concentration of Cardiac Troponins. United States participants only
Baseline, and up to 5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV027-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Hypertrophic Cardiomyopathy

Clinical Trials on Mavacamten

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings