Real-World Effectiveness of Mavacamten in Canada
- Conditions
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- Interventions
- Registration Number
- NCT06338202
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients treated with mavacamten Mavacamten Patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care
- Primary Outcome Measures
Name Time Method Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation 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 Outcome Measures
Name Time Method 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 * 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) assessmentAge 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
Trial Locations
- Locations (1)
London Health Science Centre (LHSC)
🇨🇦London, Ontario, Canada