Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US

NCT07557498 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Observational

Started

2026-01-15

Last updated

2026-04-29

Condition(s) studied

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Investigational drug(s) / intervention(s)

Mavacamten

Mavacamten: According to the product label

Study summary

The purpose of this study is to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician experiences with mavacamten treatment, in the US community-based practice

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Phase I: retrospective chart review For inclusion in the study, participants must meet ALL of the following criteria: * Are an adult aged 18 or over at baseline * Have a confirmed diagnosis of obstructive hypertrophic cardiomyopathy (HCM) * Have been prescribed mavacamten for obstructive HCM at one of the study sites between 28th April 2022 and 31st December 2024 * Have not ever been enrolled in any interventional clinical trial involving any cardiac myosin inhibitor (enrollment in observational studies is permitted) * Are not enrolled in any interventional clinical trial at study baseline Phase II: patient survey • Participants must meet all inclusion criteria of Phase I: retrospective chart review and be able to read and understand English and have access to computer or smartphone to complete the survey Exclusion Criteria: • None with the proviso that all inclusion criteria are met.

Primary outcome measure(s)

Participant blood pressure (both systolic and diastolic) — Baseline
Group 1 only
Date of diagnosis of hypertrophic cardiomyopathy — Baseline
Group 1 only
Hypertrophic cardiomyopathy genetic testing results — Baseline
Group 1 only
Family history of hypertrophic cardiomyopathy — Baseline
Group 1 only
Family history of Sudden Cardiac Death (SCD) — Baseline
Group 1 only
Participant comorbidities (cardiovascular and non-cardiovascular ) — Baseline
Group 1 only
Type of prior surgeries and procedures — Baseline and up to week 24
Group 1 only. Prior surgeries and procedures include: Septal Reduction Therapy (SRT), surgeries (valve repair/placement, left atrial appendage ligation), placement of devices (Implantable Cardioverter Defibrillator (ICD), pacemaker and cardiac resynchronization therapy) or atrial fibrillation/flutter ablation
Participant New York Heart Association (NYHA) class category — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Change in participant New York Heart Association (NYHA) class from baseline — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Duration of mavacamten treatment — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Number of mavacamten dose titrations — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Type of mavacamten dose tritration — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Clinical reason for mavacamten dose titration — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Clinical reason for mavacamten treatment discontinuation — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten discontinuation if discontinued due to LVEF<50%, — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Time from mavacamten discontinuation to Left Ventricular Ejection Fraction (LVEF) recovery — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Clinical reason for temporary mavacamten treatment interuption — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Time to temporary mavacamten treatment interruption — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten interruption if the interruption was due to LVEF<50% — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Time from mavacamten treatment interruption to Left Ventricular Ejection Fraction (LVEF) recovery — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Time to mavacamten treatment resumption — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Type of hypertrophic cardiomyopathy (HCM) background therapy prescribed — Baseline, and at weeks 4, 8, 12, 24
Group 1 only
Type of changes to hypertrophic cardiomyopathy (HCM) background therapy — At baseline, weeks 4, 8, 12, 24
Group 1 only. Type of changes include initiation, switching, discontinuation, augmentation, dose titration

Trial sites (1)

Facility	City	Region	Status
Adelphi Real World	Bollington	Macclesfield	Recruiting

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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 NCT07557498 on ClinicalTrials.gov ↗ ← All trials in the UK