Heart failure & cardiomyopathiesRandomised controlled trial
Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy
- Randomised controlled trial
- phase 3
- double-blind
Authors' conclusion
Among patients with symptomatic obstructive HCM, treatment with aficamten resulted in a significantly greater improvement in peak oxygen uptake than placebo.
Study context
- Population
- Adults with symptomatic obstructive hypertrophic cardiomyopathy
- Participants
- 282 adults
- Comparison
- Aficamten vs placebo
- Aficamtenn = 142
- Placebon = 140reference
- Primary endpoint
- Change from baseline in peak oxygen uptake (cardiopulmonary exercise testing)
- Follow-up
- Week 24
Primary result
Change in peak oxygen uptake · 24 weeks
Least-squares mean between-group difference
1.7 ml per kilogram per minute
95% CI 1.0–2.4
P < 0.001
By group
As reported in the abstract
Secondary outcomes
10 prespecified secondary end points (Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS), New York Heart Association (NYHA) class, Valsalva gradient, gradient <30 mm Hg, septal reduction therapy eligibility, total workload; tested hierarchically)
- All 10 secondary end points significantly improved with aficamten vs placebo
Safety
Adverse events
- Incidence of adverse events appeared similar in the two groups
Original publication
Summarised from the published abstract; every number is checked against it