Obstructive Hypertrophic Cardiomyopathy (oHCM)
Conditions
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.
Interventions
DRUGMavacamten
As detailed in the product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Employment status | Baseline | — |
| Body mass index (BMI) | Baseline | — |
| Obstructive hypertrophic cardiomyopathy (oHCM) disease duration | Baseline | — |
| Proportion of patients in each New York Heart Association (NYHA) functional class II and III | Baseline | — |
| Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation | Up to 1.5 years | — |
| Left ventricular ejection fraction by 2D echocardiogram (LVEFb) | Baseline | — |
| Mavacamten dose regimen | Up to 1.5 years | — |
| Proportion of patients who discontinued mavacamten | Up to 1.5 years | — |
| Duration of treatment prior to mavacamten discontinuation | Up to 1.5 years | — |
| Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation | 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 | — |
| Reason for discontinuing mavacamten treatment | 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) assessment |
| Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient | Baseline | — |
Countries
Canada
Outcome results
None listed