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Completed

NCT Number: NCT06338202

Real-World Effectiveness of Mavacamten in Canada

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.

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Key information

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

London Health Science Centre (LHSC)

London, Ontario, N6A 5A5, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mavacamten

Drug

As detailed in the product label

Primary outcomes

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

    Time frame: Up to 1.5 years

    • 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

Secondary outcomes

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

    Time frame: Up to 1.5 years

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

    Time frame: Up to 1.5 years

  3. Age

    Time frame: Baseline

  4. Sex at birth

    Time frame: Baseline

  5. Ethnicity

    Time frame: Baseline

  6. Employment status

    Time frame: Baseline

  7. Body mass index (BMI)

    Time frame: Baseline

  8. Obstructive hypertrophic cardiomyopathy (oHCM) disease duration

    Time frame: Baseline

  9. Proportion of patients in each New York Heart Association (NYHA) functional class II and III

    Time frame: Baseline

  10. Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient

    Time frame: Baseline

  11. Left ventricular ejection fraction by 2D echocardiogram (LVEFb)

    Time frame: Baseline

  12. Mavacamten dose regimen

    Time frame: Up to 1.5 years

  13. Proportion of patients who discontinued mavacamten

    Time frame: Up to 1.5 years

  14. Duration of treatment prior to mavacamten discontinuation

    Time frame: Up to 1.5 years

  15. Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation

    Time frame: Up to 1.5 years

  16. Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation

    Time frame: Up to 1.5 years

  17. Reason for discontinuing mavacamten treatment

    Time frame: Up to 1.5 years

  18. Functional assessment schedule

    Time frame: Up to 1.5 years

    • Proportion of patients who undergo left ventricular outflow tract with Valsalva maneuver gradient (vLVOT) functional assessment
    • Proportion of patients who undergo left ventricular ejection fraction (LVEF) assessment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real-World Effectiveness of MAVacamtEN in Canada (MAVEN): A Retrospective Physician Survey of Patient Charts

Acronym: MAVEN

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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