Phase III ACACIA-HCM results show significant improvements in symptoms and functional capacity with aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy.
Aficamten significantly improved symptom burden and exercise capacity in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (HCM), according to results from the phase III ACACIA-HCM trial presented at ESC Congress 2026.
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Non-obstructive HCM is characterized by abnormal thickening of the heart muscle without obstruction of blood flow. Despite the substantial symptom burden experienced by some patients, there are currently no approved therapies specifically for symptomatic non-obstructive HCM.
ACACIA-HCM enrolled 517 adults with symptomatic non-obstructive HCM across 182 international sites. Participants were randomized to receive the cardiac myosin inhibitor aficamten or placebo for up to 72 weeks.
At 36 weeks, Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) improved by 11.4 points with aficamten compared with 8.4 points with placebo (p=0.02). Peak oxygen consumption also increased by 0.64 mL/kg/min with aficamten compared with a change of −0.03 mL/kg/min with placebo (p=0.003).
Improvements were also observed across secondary endpoints, including New York Heart Association functional class, submaximal exercise performance, and N-terminal pro-B-type natriuretic peptide.
A reduction in left ventricular ejection fraction to below 50% occurred more frequently with aficamten than placebo. These reductions were reversible and were managed through dose adjustment.
The findings provide phase III evidence that targeting cardiac myosin may improve both symptoms and functional capacity in symptomatic non-obstructive HCM, an area where treatment options remain limited.
Reference
Presentation: Ahmad Masri. ACACIA-HCM: Aficamten for symptomatic nonobstructive hypertrophic cardiomyopathy. Presented during Hot Line 1 at ESC Congress 2026; August 28, 2026; Munich, Germany. The results were simultaneously published in the New England Journal of Medicine.
Cite: Aficamten improves symptoms and exercise capacity in non-obstructive HCM. touchCARDIO. September 2, 2026.
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Editor: Nicola Cartridge, Director of Content
>touchCARDIO coverage of ESC Congress 2026: This content has been developed independently by Touch Medical Media for touchCARDIO. It is not affiliated with the ESC. Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
