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

NCT07557498 | Recruiting FDA Drug

• 1 other identifier: CV027-1164
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords

Obstructive Hypertrophic cardiomyopathy (oHCM)

Outcome Measures

Primary Outcomes (23)

• Participant blood pressure (both systolic and diastolic)

  Group 1 only

  Baseline

• Date of diagnosis of hypertrophic cardiomyopathy

  Group 1 only

  Baseline

• Hypertrophic cardiomyopathy genetic testing results

  Group 1 only

  Baseline

• Family history of hypertrophic cardiomyopathy

  Group 1 only

  Baseline

• Family history of Sudden Cardiac Death (SCD)

  Group 1 only

  Baseline

• Participant comorbidities (cardiovascular and non-cardiovascular )

  Group 1 only

  Baseline

• Type of prior surgeries and procedures

  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

  Baseline and up to week 24

• Participant New York Heart Association (NYHA) class category

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Change in participant New York Heart Association (NYHA) class from baseline

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Duration of mavacamten treatment

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Number of mavacamten dose titrations

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Type of mavacamten dose tritration

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Clinical reason for mavacamten dose titration

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Clinical reason for mavacamten treatment discontinuation

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten discontinuation if discontinued due to LVEF<50%,

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Time from mavacamten discontinuation to Left Ventricular Ejection Fraction (LVEF) recovery

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Clinical reason for temporary mavacamten treatment interuption

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Time to temporary mavacamten treatment interruption

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Left Ventricular Ejection Fraction (LVEF) recovery after mavacamten interruption if the interruption was due to LVEF<50%

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Time from mavacamten treatment interruption to Left Ventricular Ejection Fraction (LVEF) recovery

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Time to mavacamten treatment resumption

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Type of hypertrophic cardiomyopathy (HCM) background therapy prescribed

  Group 1 only

  Baseline, and at weeks 4, 8, 12, 24

• Type of changes to hypertrophic cardiomyopathy (HCM) background therapy

  Group 1 only. Type of changes include initiation, switching, discontinuation, augmentation, dose titration

  At baseline, weeks 4, 8, 12, 24

Secondary Outcomes (1)

• Perspectives on treatment preference, and the eligibility, onboarding and implementation of mavacamten as assessed by feedback collated through structured physician interviews

  Up to week 24

Study Arms (2)

Group 1

Participants with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten

Drug: Mavacamten

Group 2

Physicians treating patients diagnosed with obstructive hypertrophic cardiomyopathy (oHCM)

Drug: Mavacamten

Interventions

Mavacamten DRUG

According to the product label

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults that have been diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and have received treatment with mavacamten and their treating clinicians from participating community-based sites in the US.

You may qualify if:

• Phase I: retrospective chart review
• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Adelphi Real World

Bollington, Macclesfield, SK10 5JB, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): June 17, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)