Why the study?
Available pharmacological treatments for obstructive hypertrophic cardiomyopathy are not disease-specific and often inadequate or poorly tolerated, leading investigators to assess the effect of mavacamten on patient health status.
Does mavacamten improve health status in adult patients with symptomatic obstructive hypertrophic cardiomyopathy?
Population
251 adults with symptomatic obstructive hypertrophic cardiomyopathy
Comparison
Mavacamten vs placebo
Design
Multicentre double-blind randomised placebo-controlled phase 3 trial
Follow-up
38 weeks
Key result
Mavacamten significantly improved health status in patients with symptomatic obstructive hypertrophic cardiomyopathy compared to placebo, with a mean KCCQ-OS score difference of +9.1 (P<0.0001).
Authors
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Mavacamten significantly improves symptoms, physical function, and quality of life in patients with symptomatic obstructive hypertrophic cardiomyopathy.
RCT (n=251)
double-blind
1:1
Yes
Does mavacamten improve health status in adult patients with symptomatic obstructive hypertrophic cardiomyopathy?
Mean Difference: 9.1 (95% CI 5.5–12.8)
Absolute Event Rate: 14.9% vs 5.4%
Absolute Risk Reduction: 21%
Number Needed to Treat: 5
p-value: p=<0.0001
Mavacamten significantly improves symptoms, physical function, and quality of life in patients with symptomatic obstructive hypertrophic cardiomyopathy.
Spertus et al. (2021) conducted an RCT in symptomatic obstructive hypertrophic cardiomyopathy (n=251). mavacamten vs. placebo was evaluated on Change from baseline to week 30 in KCCQ overall summary (OS) score (MD 9.1, 95% CI 5.5-12.8, p=<0.0001). Mavacamten significantly improved health status in patients with symptomatic obstructive hypertrophic cardiomyopathy compared to placebo, with a mean KCCQ-OS score difference of +9.1 (P<0.0001).
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