Heart failure & cardiomyopathies
Aficamten and Cardiopulmonary Exercise Test Performance: A Substudy of the SEQUOIA-HCM Randomized Clinical Trial
Primary resultResult — go to the resultPlacebo-corrected improvement 0.35 z score 95% CI 0.25–0.46Authors' conclusion
This prespecified analysis of the SEQUOIA-HCM randomized clinical trial found that aficamten treatment improved a broad range of exercise performance measures.
Study context
- Population
- Symptomatic obstructive hypertrophic cardiomyopathy (HCM) with objective exertional intolerance (pVO2 ≤90% predicted)263 with validated CPET
- Participants
- 282 participants
- Comparison
- Aficamten vs placebo
- Primary endpoint
- Change in integrated exercise performance (2-component z score of pVO2 and VE/VCO2 slope)
- Follow-up
- Baseline to week 24
Methodological detailsprespecified analysis, double-blind, placebo-controlled, multicentre (101 sites, 14 countries)
- Prespecified analysis
- Double-blind
- Placebo-controlled
- Multicentre (101 sites, 14 countries)
Primary result
As reported in the abstract
Placebo-corrected improvement
0.35 z score
95% CI 0.25–0.46
P < 0.001
By group
Aficamten
0.17
mean · SD 0.51 · z score
Placebo
−0.19
mean · SD 0.45 · z score
Further findings
pVO2 large improvement / large reduction (≥3.0 mL/kg per minute)
Large improvement
Large reduction
Total workload, circulatory power, exercise duration, HR reserve, peak HR, ventilatory efficiency, ventilatory power, anaerobic threshold
- Significant improvements with aficamten
- all P <.001
Correlation of pVO2 and VE/VCO2 slope improvements with symptom burden and hemodynamics
- Significantly correlated
- all P <.05
Original publication
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