Heart drug mavacamten under the microscope: new registry tracks Real-Life results

NCT ID NCT05489705

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study is a large registry that will follow about 1,700 people with obstructive hypertrophic cardiomyopathy in the US and Europe. Researchers will track how patients respond to mavacamten or other standard treatments in real-world settings, focusing on safety and effectiveness. The goal is to better understand long-term outcomes and treatment patterns outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Mavacamten
What this could lead to: If successful, this study could provide a clearer picture of how well mavacamten works and its safety in everyday medical practice for people with obstructive hypertrophic cardiomyopathy.
What could go wrong: This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by differences in patient care and reporting across sites.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

heart failure hypertrophic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive hypertrophic cardiomyopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

80 sites in 7 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Alaska Heart Institute
RECRUITING

Anchorage, Alaska, 99508, United States
BI Research Center
RECRUITING

Houston, Texas, 77084, United States
Bassett Medical Center
RECRUITING

Cooperstown, New York, 13326, United States
Baylor Scott & White Medical Centre - Temple
RECRUITING

Temple, Texas, 76508, United States
Baylor Scott & White Research Institute
RECRUITING

Dallas, Texas, 75246, United States
Baylor Scott & White The Heart Hospital Plano
RECRUITING

Plano, Texas, 75093, United States
CHI Health Reseach Center
RECRUITING

Omaha, Nebraska, 68124, United States
CHU Amiens-Picardie
RECRUITING

Amiens, Somme, 80054, France
CHU De Poitiers - Hopital De La Miletrie
RECRUITING

Poitiers, Vienne, 86000, France
CHU Nantes Hopital Nord Laennec
RECRUITING

Saint-Herblain, Loire Atlantique, 44800, France
Cardiology Associates Research, Llc
RECRUITING

Tupelo, Mississippi, 38801, United States
Carilion Clinic; Virginia Tech-Carilion School of Medicine
RECRUITING

Roanoke, Virginia, 24014, United States
Centre Hospitalier Haguenau
RECRUITING

Haguenau, Bas Rhin, 67500, France
Christ Hospital Health Network
RECRUITING

Cincinnati, Ohio, 45219, United States
Duke University Health System
RECRUITING

Durham, North Carolina, 27710, United States
Focus Clinical Research
RECRUITING

Charlotte, North Carolina, 28207, United States
Franciscan Physician Network-Indiana Heart Physicians
RECRUITING

Indianapolis, Indiana, 46237, United States
Geisinger Health System
RECRUITING

Wilkes-Barre, Pennsylvania, 18711, United States
Hackensack University Medical Center
RECRUITING

Hackensack, New Jersey, 07601, United States
Harvard (Massachusetts General Hospital)
RECRUITING

Boston, Massachusetts, 02114, United States
Harvard Medical School - Brigham and Women's Hospital (BWH)
RECRUITING

Boston, Massachusetts, 02215, United States
Henry Ford Health System
RECRUITING

West Bloomfield, Michigan, 48322, United States
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital Clinico Universitario Virgen de La Victoria
RECRUITING

Málaga, 29010, Spain
Hospital Fundacion Son Llatzer
RECRUITING

Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital Universitario Central de Asturias
RECRUITING

Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING

Majadahonda, Madrid, 28222, Spain
Hospital Universitario Virgen de La Arrixaca
RECRUITING

El Palmar, Murcia, 30120, Spain
Hospital Universitario de Burgos
RECRUITING

Burgos, 09006, Spain
Hôpital Saint Vincent-de-Paul
RECRUITING

Lille, Nord, 59000, France
Hôpital Sainte Musse
RECRUITING

Toulon, Var, 83000, France
Immanuel Klinikum Bernau
RECRUITING

Bernau, State of Berlin, 16321, Germany
Imperial College Healthcare NHS Trust
RECRUITING

London, Greater London, W6 8RF, United Kingdom
Indiana. University
RECRUITING

Indianapolis, Indiana, 46202, United States
KH St.Josef Braunau am Inn
RECRUITING

Braunau am Inn, 5280, Austria
Kardiologische und angiologische Praxen im Spreebogen
RECRUITING

Berlin, 10719, Germany
Keck School of Medicine of USC-Usc
RECRUITING

Los Angeles, California, 90033, United States
Kepler Universitätsklinikum Linz
RECRUITING

Linz, 4021, Austria
LKH-Univ. Klinikum Graz
RECRUITING

Graz, 8036, Austria
Leeds General Infirmary
RECRUITING

Leeds, West Yorkshire, LS1 3EX, United Kingdom
Liverpool Heart and Chest Hospital
RECRUITING

Liverpool, Merseyside, L14 3PE, United Kingdom
Local Institution - 0001
WITHDRAWN

Prague, 150 00, Czechia
Local Institution - 0001
WITHDRAWN

Warsaw, 04-628, Poland
Local Institution - 0002
WITHDRAWN

Olomouc, 779 00, Czechia
Local Institution - 0002
WITHDRAWN

Katowice, 40-635, Poland
Local Institution - 0003
ACTIVE_NOT_RECRUITING

Cleveland, Ohio, 44195, United States
Local Institution - 0004
ACTIVE_NOT_RECRUITING

Madison, Wisconsin, 53792, United States
Local Institution - 0009
ACTIVE_NOT_RECRUITING

New York, New York, 10019, United States
Local Institution - 0026
ACTIVE_NOT_RECRUITING

Morristown, New Jersey, 07960, United States
Local Institution - 0033
ACTIVE_NOT_RECRUITING

Kansas City, Missouri, 66160, United States
Local Institution - 0037
ACTIVE_NOT_RECRUITING

La Jolla, California, 92037, United States
Local Institution - 0045
ACTIVE_NOT_RECRUITING

Iowa City, Iowa, 52242, United States
Local Institution - 0046
ACTIVE_NOT_RECRUITING

Honolulu, Hawaii, 96813, United States
Local Institution - 0059
ACTIVE_NOT_RECRUITING

Baltimore, Maryland, 21201, United States
Local Institution - 0065
ACTIVE_NOT_RECRUITING

Jacksonville, Florida, 32209, United States
Local Institution - 0067
ACTIVE_NOT_RECRUITING

Hartford, Connecticut, 06106, United States
Local Institution - 0076
ACTIVE_NOT_RECRUITING

Lancaster, Pennsylvania, 17603, United States
Local Institution - 0083
NOT_YET_RECRUITING

Vienna, 1090, Austria
Local Institution - 0084
WITHDRAWN

Klagenfurt, 9020, Austria
Local Institution - 0085
NOT_YET_RECRUITING

Sankt Pölten, 3100, Austria
Local Institution - 0088
NOT_YET_RECRUITING

Innsbruck, 6020, Austria
Local Institution - 0101
WITHDRAWN

Erlangen, Bavaria, 91054, Germany
Local Institution - 0102
WITHDRAWN

Madrid, 28007, Spain
Local Institution - 0110
ACTIVE_NOT_RECRUITING

Birmingham, West Midlands, B15 2GW, United Kingdom
Local Institution - 0113
NOT_YET_RECRUITING

London, Greater London, SW3 6NP, United Kingdom
Local Institution - 0117
WITHDRAWN

Montpellier, 34000, France
MedStar Health Research Institute
RECRUITING

Baltimore, Maryland, 21218, United States
MedStar Washington Hospital Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Medical College of Wisconsin, Inc (PI Address)
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Minneapolis Heart Institute Foundation
RECRUITING

Minneapolis, Minnesota, 55407, United States
Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
North Texas Cardiology Center
RECRUITING

Dallas, Texas, 75208, United States
Ostalb-Klinikum Aalen
RECRUITING

Aalen, Baden-Wurttemberg, 73430, Germany
Pima Heart and Vascular
RECRUITING

Tucson, Arizona, 85704, United States
Praxisklinik Herz Und Gefasse-Klinikum Weisser Hirsch
RECRUITING

Dresden, Saxony, 01099, Germany
Prisma Health - Upstate
RECRUITING

Greenville, South Carolina, 29605, United States
Research & Cardiovascular Corp
RECRUITING

Ponce, 00717-1322, Puerto Rico
Saint Francis Hospital
RECRUITING

Roslyn, New York, 11576, United States
Saint Thomas Health
RECRUITING

Nashville, Tennessee, 37205-2018, United States
Spectrum Health Medical Group
RECRUITING

Grand Rapids, Michigan, 49525, United States
St. Luke's Mid-America Heart Institute
RECRUITING

Kansas City, Missouri, 64111, United States
St. Luke's University Health Network
RECRUITING

Bethlehem, Pennsylvania, 18015, United States
Stanford Health Care Hospital & Clinics
RECRUITING

Palo Alto, California, 94304, United States
The Methodist Hospital, Methodist Cancer Cencer
RECRUITING

Houston, Texas, 77030, United States
The Rector and Visitors of the Univ of Virginia
RECRUITING

Charlottesville, Virginia, 22908, United States
Tristar Centennial Medical Ctr
RECRUITING

Nashville, Tennessee, 37203, United States
UAMS
RECRUITING

Little Rock, Arkansas, 72205-7199, United States
UC Denver, AMC
RECRUITING

Aurora, Colorado, 48377, United States
Universitaetsklinikum Leipzig Aoer
RECRUITING

Leipzig, Saxony, 04103, Germany
Universitatsklinikum Muenster
RECRUITING

Münster, North Rhine-Westphalia, 48149, Germany
University Hospital of Wales
RECRUITING

Cardiff, CF14 4XW, United Kingdom
University Hospitals Cleveland Medical Center
RECRUITING

Cleveland, Ohio, 44106, United States
University Of California San Francisco Medical Center
RECRUITING

San Francisco, California, 94117, United States
University Of Manchester
RECRUITING

Manchester, Greater Manchester, M13 9WL, United Kingdom
University Of Pittsburgh
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
University of Chicago Dept of Medicine
RECRUITING

Chicago, Illinois, 60637, United States
VCU Medical Center
RECRUITING

Richmond, Virginia, 23298, United States
Virginia Mason Medical Center
RECRUITING

Seattle, Washington, 98101, United States
WMCHealth Advanced Physician Services
RECRUITING

Valhalla, New York, 10595, United States
WVU Hospitals
RECRUITING

Morgantown, West Virginia, 26506, United States
Washington University
RECRUITING

St Louis, Missouri, 63110, United States

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