A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US

NCT07107373 | Active Not Recruiting FDA Drug

• 1 other identifier: CV027-1152
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Outcome Measures

Primary Outcomes (3)

• New York Heart Association (NYHA) functional class

  Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index

• Left ventricular outflow tract (LVOT) gradient and associated parameters

  Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index

• Left ventricular ejection fraction (LVEF) and associated parameters

  Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index

Secondary Outcomes (8)

• Mavacamten dose at initiation

  Day 1

• Mavacamten dose change

  Up to 72 weeks

• Reason for mavacamten dose change

  Up to 72 weeks

• Reason for mavacamten permanent discontinuation

  Up to 72 weeks

• Reason for treatment interruption

  Up to 72 weeks

Study Arms (1)

Participants receiving treatment mavacamten

Drug: Mavacamten

Interventions

Mavacamten DRUG

According to the product label

Participants receiving treatment mavacamten

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 comprise of adult individuals diagnosed with Obstructive hypertrophic cardiomyopathy (oHCM) that have been prescribed mavacamten treatment between April 29th, 2022, and August 6th, 2024

You may qualify if:

• Age ≥ 18 years at the index date
• Prescription of mavacamten for the treatment of Obstructive hypertrophic cardiomyopathy (oHCM) with NYHA Class II or III
• ≥ 12 weeks of follow-up after prescription of mavacamten, except for the baseline data reporting

You may not qualify if:

• Data collection as part of a clinical trial during the study period
• Participation in a myosin inhibitor clinical trial

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

University of California, San Francisco (UCSF)

San Francisco, California, 94118, United States

Location

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

Study Design

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

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: December 22, 2023
• Primary Completion: July 26, 2024
• Study Completion: December 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)