Obstructive Hypertrophic Cardiomyopathy (oHCM)
Conditions
Brief summary
The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US
Interventions
DRUGMavacamten
According to 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
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years at the index date * Prescription of mavacamten for the treatment of Obstructive hypertrophic cardiomyopathy (oHCM) with NYHA Class II or III * ≥ 12 weeks of follow-up after prescription of mavacamten, except for the baseline data reporting
Exclusion criteria
* Data collection as part of a clinical trial during the study period * Participation in a myosin inhibitor clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New York Heart Association (NYHA) functional class | Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index |
| Left ventricular outflow tract (LVOT) gradient and associated parameters | Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index |
| Left ventricular ejection fraction (LVEF) and associated parameters | Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, and in increments of 12 weeks thereafter from index |
Secondary
| Measure | Time frame |
|---|---|
| Reason for mavacamten permanent discontinuation | Up to 72 weeks |
| Reason for treatment interruption | Up to 72 weeks |
| Mavacamten dose at initiation | Day 1 |
| Concurrent Obstructive hypertrophic cardiomyopathy (oHCM) therapies | Up to 72 weeks |
| Other cardiovascular-related treatments prescribed | Up to 72 weeks |
| Prior Obstructive hypertrophic cardiomyopathy (oHCM) therapies | Baseline |
| Mavacamten dose change | Up to 72 weeks |
| Reason for mavacamten dose change | Up to 72 weeks |
Countries
United States
Outcome results
None listed