We are pleased to share that Us2.ai's software was used to support echocardiographic core laboratory analysis in ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), a landmark Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy.
The Brigham and Women's Hospital Cardiovascular Imaging Core Laboratory performed blinded echocardiographic analysis according to American Society of Echocardiography guidelines, using Us2.ai's software to support this work across the trial's study sites.
About the trial
ACACIA-HCM is the first Phase 3 clinical trial to successfully demonstrate statistically significant improvements across both patient-reported and physician-assessed endpoints in non-obstructive HCM, meeting its dual primary endpoints of improved symptom burden as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and improved maximal exercise performance at 36 weeks compared to placebo. A total of 258 patients were enrolled, with a mean age of 55 years.
Non-obstructive HCM is a relatively common form of inherited heart disease for which there are currently no approved treatments. The positive results from ACACIA-HCM have led Cytokinetics to plan a Supplemental New Drug Application submission to the FDA in Q4 2026.
We are proud to have contributed tools that supported standardised, high-quality echocardiographic analysis across the trial's study sites, advancing cardiac imaging in one of the most clinically significant HCM trials conducted to date.
Hegde, S. M., Wang, X., Bhatia, A., Peña-Peña, M. L., Sherrid, M. V., Figueiredo, E. L., Arad, M., Barriales-Villa, R., Choudhury, L., Claggett, B. L., Coats, C. J., de Barros Correia, E., Costabel, J. P., Elliott, P. M., Silva Enciso, J. E., Garcia-Pavia, P., Ge, J., Ho, C. Y., Lakdawala, N. K., … Mudd, J. (2026). Effect of Aficamten on Cardiac Structure and Function in Patients with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy. Circulation. https://doi.org/10.1161/circulationaha.126.082343