A PHASE 3 MULTI-CENTER RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO PLACEBO IN ADULTS WITH SYMPTOMATIC NON-OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY

Brief description of study

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial in participants with symptomatic nHCM. Approximately 420 eligible participants will be randomized in a 1:1 ratio to aficamten or placebo. Doses of 5, 10, 15, or 20 mg aficamten or matching placebo will be administered in an escalating manner using echocardiography to guide dose titration. Randomization will be stratified by persistent atrial fibrillation and presence of intracavitary obstruction. This Phase 3 trial of aficamten in participants with nHCM is designed to further evaluate the effect of aficamten on quality of life, exercise capacity, heart failure symptoms, cardiac biomarkers, cardiac remodeling, and clinical outcomes. Additionally, the safety and tolerability of aficamten will be assessed in participants with nHCM. This multinational trial will be conducted at approximately 150 investigational sites. Approximately 420 participants will be randomized across all sites.


Clinical Study Identifier: s23-01100
ClinicalTrials.gov Identifier: NCT06081894
Principal Investigator: Mark V. Sherrid.
Other Investigators: Daniele Massera, Kristen Marie Rodriguez, Woon Yee Wu, Maria Reuter.


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