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)

Recruiting · NCT05489705 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bristol-Myers Squibb

View the official record on ClinicalTrials.gov →

Heart failure

Interventions studied

MavacamtenNon-mavacamten symptomatic oHCM therapy

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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

Where it is running

60 locations listed across 31 US states.

Alaska Heart Institute - Anchorage, Alaska, United States
Pima Heart and Vascular - Tucson, Arizona, United States
UAMS - Little Rock, Arkansas, United States
Local Institution - 0037 - La Jolla, California, United States
Keck School of Medicine of USC-Usc - Los Angeles, California, United States
Stanford Health Care Hospital & Clinics - Palo Alto, California, United States
University Of California San Francisco Medical Center - San Francisco, California, United States
UC Denver, AMC - Aurora, Colorado, United States
Local Institution - 0067 - Hartford, Connecticut, United States
MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
Local Institution - 0065 - Jacksonville, Florida, United States
Local Institution - 0046 - Honolulu, Hawaii, United States
University of Chicago Dept of Medicine - Chicago, Illinois, United States
Indiana. University - Indianapolis, Indiana, United States
Franciscan Physician Network-Indiana Heart Physicians - Indianapolis, Indiana, United States
Local Institution - 0045 - Iowa City, Iowa, United States
Local Institution - 0059 - Baltimore, Maryland, United States
MedStar Health Research Institute - Baltimore, Maryland, United States
Harvard (Massachusetts General Hospital) - Boston, Massachusetts, United States
Harvard Medical School - Brigham and Women's Hospital (BWH) - Boston, Massachusetts, United States
Spectrum Health Medical Group - Grand Rapids, Michigan, United States
Henry Ford Health System - West Bloomfield, Michigan, United States
Minneapolis Heart Institute Foundation - Minneapolis, Minnesota, United States
Cardiology Associates Research, Llc - Tupelo, Mississippi, United States
St. Luke's Mid-America Heart Institute - Kansas City, Missouri, United States
Local Institution - 0033 - Kansas City, Missouri, United States
Washington University - St Louis, Missouri, United States
CHI Health Reseach Center - Omaha, Nebraska, United States
Hackensack University Medical Center - Hackensack, New Jersey, United States
Local Institution - 0026 - Morristown, New Jersey, United States
Bassett Medical Center - Cooperstown, New York, United States
Local Institution - 0009 - New York, New York, United States
Mount Sinai Hospital - New York, New York, United States
Saint Francis Hospital - Roslyn, New York, United States
WMCHealth Advanced Physician Services - Valhalla, New York, United States
Focus Clinical Research - Charlotte, North Carolina, United States
Duke University Health System - Durham, North Carolina, United States
Christ Hospital Health Network - Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
Local Institution - 0003 - Cleveland, Ohio, United States
St. Luke's University Health Network - Bethlehem, Pennsylvania, United States
Local Institution - 0076 - Lancaster, Pennsylvania, United States
University Of Pittsburgh - Pittsburgh, Pennsylvania, United States
Geisinger Health System - Wilkes-Barre, Pennsylvania, United States
Prisma Health - Upstate - Greenville, South Carolina, United States
Tristar Centennial Medical Ctr - Nashville, Tennessee, United States
Saint Thomas Health - Nashville, Tennessee, United States
North Texas Cardiology Center - Dallas, Texas, United States
Baylor Scott & White Research Institute - Dallas, Texas, United States
The Methodist Hospital, Methodist Cancer Cencer - Houston, Texas, United States
BI Research Center - Houston, Texas, United States
Baylor Scott & White The Heart Hospital Plano - Plano, Texas, United States
Baylor Scott & White Medical Centre - Temple - Temple, Texas, United States
The Rector and Visitors of the Univ of Virginia - Charlottesville, Virginia, United States
VCU Medical Center - Richmond, Virginia, United States
Carilion Clinic; Virginia Tech-Carilion School of Medicine - Roanoke, Virginia, United States
Virginia Mason Medical Center - Seattle, Washington, United States
WVU Hospitals - Morgantown, West Virginia, United States
Local Institution - 0004 - Madison, Wisconsin, United States
Medical College of Wisconsin, Inc (PI Address) - Milwaukee, Wisconsin, United States

Showing 60 of 101 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →