NCT06338202CompletedNot Applicable
Real-World Effectiveness of MAVacamtEN in Canada (MAVEN): A Retrospective Physician Survey of Patient Charts
Bristol-Myers Squibb1 site in 1 country115 target enrollmentStarted: June 24, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Patients treated with mavacamten
Patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care
Intervention: Mavacamten (Drug)
Outcomes
Primary Outcomes
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
- Obstructive hypertrophic cardiomyopathy (oHCM) disease duration(Baseline)
- Duration of treatment prior to mavacamten discontinuation(Up to 1.5 years)
- Functional assessment schedule(Up to 1.5 years)
- Age(Baseline)
- Proportion of patients in each New York Heart Association (NYHA) functional class II and III(Baseline)
- Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation(Up to 1.5 years)
- Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation(Up to 1.5 years)
- Ethnicity(Baseline)
- Employment status(Baseline)
- Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient(Baseline)
- Left ventricular ejection fraction by 2D echocardiogram (LVEFb)(Baseline)
- Proportion of patients who discontinued mavacamten(Up to 1.5 years)
- Reason for discontinuing mavacamten treatment(Up to 1.5 years)
- Sex at birth(Baseline)
- Body mass index (BMI)(Baseline)
- Mavacamten dose regimen(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)
- Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation(Up to 1.5 years)
Investigators
Study Sites (1)
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