Recruiting

Mavacamten, Other TreatmentsA 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)

Sponsor:

Bristol-Myers Squibb

Code:

NCT05489705

Conditions

Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mavacamten

Non-mavacamten symptomatic oHCM therapy

Study Details

Brief 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.

Conditions

Obstructive Hypertrophic Cardiomyopathy

Study ID

NCT05489705

Start date

Aug 16, 2022

Status verified date

Aug, 2026

Completion date

Aug 17, 2029

Anticipated

Primary completion date

Aug 17, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1700 participants

Anticipated

Interventions and Outcome Measures

Arms

Mavacamten

Participants will receive mavacamten as prescribed by a physician according to standard of care for symptomatic oHCM

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

Interventions

Mavacamten

As per product label

Non-mavacamten symptomatic oHCM therapy

Including Beta-blocker (BB), non-dihydropyridine (non-DHP) calcium channel blocker (CCB) and/or disopyramide as per product label

Primary outcome measure

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 ]
Change in resting left ventricular outflow tract (LVOT) gradient from baseline [ Time Frame: Up to 18 months ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

Locations

Alaska Heart Institute

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Ahmed Abuzaid, Site 0023

907-561-3211

Pima Heart and Vascular

Recruiting

Tucson, Arizona, United States, 85704

Contacts

Greg Koshkarian, Site 0025

000-000-0000

UAMS

Recruiting

Little Rock, Arkansas, United States, 72205-7199

Contacts

Srikanth Vallurupalli, Site 0007

501-686-5545

Keck School of Medicine of USC-Usc

Recruiting

Los Angeles, California, United States, 90033

Contacts

Eugene DePasquale, Site 0057

323-442-6130

Stanford Health Care Hospital & Clinics

Recruiting

Palo Alto, California, United States, 94304

University Of California San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94117

UC Denver, AMC

Recruiting

Aurora, Colorado, United States, 48377

Contacts

David Raymer, Site 0050

720-848-5300

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Patrick Bering, Site 0081

202-877-5975

University of Chicago Dept of Medicine

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Gene Kim, Site 0063

773-702-9396

Indiana. University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Roopa Rao, Site 0013

317-962-9700

Franciscan Physician Network-Indiana Heart Physicians

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

George Lolay, Site 0016

317-893-1712

MedStar Health Research Institute

Recruiting

Baltimore, Maryland, United States, 21218

Harvard (Massachusetts General Hospital)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Albree Tower-Rader, Site 0024

617-724-5434

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

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Carolyn Ho, Site 0068

617-732-5500

Spectrum Health Medical Group

Recruiting

Grand Rapids, Michigan, United States, 49525

Contacts

David Fermin, Site 0073

616-885-5000

Henry Ford Health System

Recruiting

West Bloomfield, Michigan, United States, 48322

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Robert Fraser, Site 0010

612-863-3900

Cardiology Associates Research, Llc

Recruiting

Tupelo, Mississippi, United States, 38801

Contacts

Barry Bertolet, Site 0062

904-392-2469

St. Luke's Mid-America Heart Institute

Recruiting

Kansas City, Missouri, United States, 64111

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Richard Bach, Site 0036

314-362-1963

CHI Health Reseach Center

Recruiting

Omaha, Nebraska, United States, 68124

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Dmitry Nemirovsky, Site 0029

551-996-5870

Bassett Medical Center

Recruiting

Cooperstown, New York, United States, 13326

Contacts

Mun Hong, Site 0006

607-547-4582

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Johanna Contreras, Site 0035

917-751-5850

Saint Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Contacts

Allen Jeremias, Site 0075

631-707-2586

WMCHealth Advanced Physician Services

Recruiting

Valhalla, New York, United States, 10595

Contacts

Srihari Naidu, Site 0053

914-598-7651

Focus Clinical Research

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Aamer Qurehshi, Site 0040

888-635-0552

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

Christ Hospital Health Network

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Wojciech Mazur, Site 0015

513-721-8881

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Anene Clair Ukaigwe, Site 0041

216-286-1023

St. Luke's University Health Network

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Jamshid Shirani, Site 0043

718-430-3314

University Of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Geisinger Health System

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Vernon Mascarenhas, Site 0056

570-808-6020

Prisma Health - Upstate

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Josh Doll, Site 0042

864-455-7727

Tristar Centennial Medical Ctr

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Bryan Doherty, Site 0048

347-949-3060

Saint Thomas Health

Recruiting

Nashville, Tennessee, United States, 37205-2018

Contacts

Mark Zenker, Site 0019

615-269-4545

North Texas Cardiology Center

Recruiting

Dallas, Texas, United States, 75208

Contacts

Manavjot Sidhu, Site 0018

214-933-7430

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75246

The Methodist Hospital, Methodist Cancer Cencer

Recruiting

Houston, Texas, United States, 77030

Contacts

Sherif Nagueh, Site 0058

713-441-2850

BI Research Center

Recruiting

Houston, Texas, United States, 77084

Contacts

Asif Akhtar, Site 0039

281-944-3610

Baylor Scott & White The Heart Hospital Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

David Rawitscher, Site 0028

469-800-6390

Baylor Scott & White Medical Centre - Temple

Recruiting

Temple, Texas, United States, 76508

Contacts

Vinh Nguyen, Site 0051

254-724-5119

The Rector and Visitors of the Univ of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Christopher Kramer, Site 0011

434-982-0853

VCU Medical Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Mohammed Makkiya, Site 0080

804-828-9989

Carilion Clinic; Virginia Tech-Carilion School of Medicine

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Ali Hama Amin, Site 0044

540-982-8204

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Mariko Harper, Site 0052

206-341-1111

WVU Hospitals

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Christopher Bianco, Site 0055

304-598-4000

Medical College of Wisconsin, Inc (PI Address)

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Abhinav Sharma, Site 0054

414-805-6000

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

Obstructive hypertrophic cardiomyopathy
Obstructive HCM (oHCM)
Mavacamten
Heart failure
oHCM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-19.