Clinical trial NCT06338202: Real-World Effectiveness of Mavacamten in Canada
Official title: Real-World Effectiveness of MAVacamtEN in Canada (MAVEN): A Retrospective Physician Survey of Patient Charts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation
timeFrame: Up to 1.5 years
Secondary outcomes:
measure: Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation
timeFrame: Up to 1.5 years
measure: Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation
timeFrame: Up to 1.5 years
measure: Age
timeFrame: Baseline
measure: Sex at birth
timeFrame: Baseline
measure: Ethnicity
timeFrame: Baseline
measure: Employment status
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: Baseline
measure: Obstructive hypertrophic cardiomyopathy (oHCM) disease duration
timeFrame: Baseline
measure: Proportion of patients in each New York Heart Association (NYHA) functional class II and III
timeFrame: Baseline
measure: Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient
timeFrame: Baseline
measure: Left ventricular ejection fraction by 2D echocardiogram (LVEFb)
timeFrame: Baseline
measure: Mavacamten dose regimen
timeFrame: Up to 1.5 years
measure: Proportion of patients who discontinued mavacamten
timeFrame: Up to 1.5 years
measure: Duration of treatment prior to mavacamten discontinuation
timeFrame: Up to 1.5 years
measure: Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation
timeFrame: Up to 1.5 years
measure: Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation
timeFrame: Up to 1.5 years
measure: Reason for discontinuing mavacamten treatment
timeFrame: Up to 1.5 years
measure: Functional assessment schedule
timeFrame: Up to 1.5 years
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Centre (LHSC)
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: