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Clinical Trials in the UK / NCT05489705
Recruiting Observational

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)

NCT05489705 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2022-08-16
Last updated
2026-08-19

Condition(s) studied

Obstructive Hypertrophic Cardiomyopathy

Investigational drug(s) / intervention(s)

MavacamtenNon-mavacamten symptomatic oHCM therapy

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

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (101)

FacilityCityRegionStatus
Alaska Heart Institute Anchorage Alaska Recruiting
Pima Heart and Vascular Tucson Arizona Recruiting
UAMS Little Rock Arkansas Recruiting
Local Institution - 0037 La Jolla California Active Not Recruiting
Keck School of Medicine of USC-Usc Los Angeles California Recruiting
Stanford Health Care Hospital & Clinics Palo Alto California Recruiting
University Of California San Francisco Medical Center San Francisco California Recruiting
UC Denver, AMC Aurora Colorado Recruiting
Local Institution - 0067 Hartford Connecticut Active Not Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
Local Institution - 0065 Jacksonville Florida Active Not Recruiting
Local Institution - 0046 Honolulu Hawaii Active Not Recruiting
University of Chicago Dept of Medicine Chicago Illinois Recruiting
Indiana. University Indianapolis Indiana Recruiting
Franciscan Physician Network-Indiana Heart Physicians Indianapolis Indiana Recruiting
Local Institution - 0045 Iowa City Iowa Active Not Recruiting
Local Institution - 0059 Baltimore Maryland Active Not Recruiting
MedStar Health Research Institute Baltimore Maryland Recruiting
Harvard (Massachusetts General Hospital) Boston Massachusetts Recruiting
Harvard Medical School - Brigham and Women's Hospital (BWH) Boston Massachusetts Recruiting
Spectrum Health Medical Group Grand Rapids Michigan Recruiting
Henry Ford Health System West Bloomfield Michigan Recruiting
Minneapolis Heart Institute Foundation Minneapolis Minnesota Recruiting
Cardiology Associates Research, Llc Tupelo Mississippi Recruiting
St. Luke's Mid-America Heart Institute Kansas City Missouri Recruiting
Local Institution - 0033 Kansas City Missouri Active Not Recruiting
Washington University St Louis Missouri Recruiting
CHI Health Reseach Center Omaha Nebraska Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Local Institution - 0026 Morristown New Jersey Active Not Recruiting
Bassett Medical Center Cooperstown New York Recruiting
Local Institution - 0009 New York New York Active Not Recruiting
Mount Sinai Hospital New York New York Recruiting
Saint Francis Hospital Roslyn New York Recruiting
WMCHealth Advanced Physician Services Valhalla New York Recruiting
Focus Clinical Research Charlotte North Carolina Recruiting
Duke University Health System Durham North Carolina Recruiting
Christ Hospital Health Network Cincinnati Ohio Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Local Institution - 0003 Cleveland Ohio Active Not Recruiting

+ 61 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05489705 on ClinicalTrials.gov ↗ ← All trials in the UK