Real-World Effectiveness of Mavacamten in Canada

NCT06338202 | Completed FDA Drug

• 1 other identifier: CV027-1137
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada.

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Outcome Measures

Primary Outcomes (1)

• Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation

  * Proportion of patients in each New York Heart Association (NYHA) functional class following mavacamten treatment initiation * Proportion of patients with a reduction of ≥1 New York Heart Association (NYHA) functional class following mavacamten treatment initiation

  Up to 1.5 years

Secondary Outcomes (18)

• Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation

  Up to 1.5 years

• Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation

  Up to 1.5 years

• Age

  Baseline

• Sex at birth

  Baseline

• Ethnicity

  Baseline

Study Arms (1)

Patients treated with mavacamten

Patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care

Drug: Mavacamten

Interventions

Mavacamten DRUG

As detailed in the product label

Patients treated with mavacamten

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The observational study will include adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who are enrolled in the Bristol Myers Squibb (BMS)-sponsored CAMZYOS Patient Support Program and who have initiated mavacamten as part of routine clinical care in Canada.

You may qualify if:

• Patients who have initiated mavacamten, as part of routine clinical care, through the Bristol Myers Squibb CAMZYOS Patient Support Program for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
• Adult patient (≥18 years of age or as defined per local province/territory) at Index Date (first prescribed dose of mavacamten).
• Patient has been diagnosed with symptomatic oHCM of New York Heart Association (NYHA) class II to III at the time of mavacamten initiation.

You may not qualify if:

• In the 6 weeks prior to baseline (i.e., Index Date; date of first prescribed dose of mavacamten), patient has received any cardiac myosin inhibitor (including mavacamten) for oHCM or any other medical condition as part of a clinical trial.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

London Health Science Centre (LHSC)

London, Ontario, N6A 5A5, Canada

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: March 25, 2024
• First Posted: March 29, 2024
• Study Start: June 24, 2024
• Primary Completion: November 12, 2024
• Study Completion: December 19, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)