Hypertrophic Cardiomyopathy Clinical Trials
SEQUOIA-HCM
SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM)
Status: Enrolling
SEQUOIA-HCM is a Phase 3 randomized, placebo-controlled, double-blind, multi-center clinical trial designed to evaluate aficamten in patients with symptomatic oHCM on background medical therapy for 24 weeks.
The primary objective is to assess the effect of aficamten on change in peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) from baseline to week 24. Secondary objectives include change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to week 12 and week 24, the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class from baseline to week 12 and week 24, change in post-Valsalva left ventricular outflow tract gradient (LVOT-G) to week 12 and week 24, the proportion of patients with post-Valsalva LVOT-G <30 mmHg, and change in total workload during CPET to week 24.
REDWOOD-HCM
REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM)
Status: Complete
REDWOOD-HCM was a Phase 2, multi-center, randomized, placebo-controlled, double-blind, dose finding clinical trial of aficamten in patients with symptomatic HCM. The primary objective of the trial was to determine the safety and tolerability of aficamten.
The secondary objectives were to describe the concentration-response and dose-response relationship of aficamten on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment. Cohorts 1 and 2 enrolled 28 patients with symptomatic obstructive HCM taking background medications exclusive of disopyramide. Cohort 3 enrolled 13 patients with symptomatic obstructive HCM taking background medications including disopyramide. Cohort 4 enrolled 41 patients with non-obstructive HCM.
FOREST-HCM
FOREST-HCM (Follow-Up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in in HCM)
Status: Enrolling by invitation
FOREST-HCM (previously known as REDWOOD-HCM OLE) is an open-label extension clinical study designed to assess the long-term safety and tolerability of aficamten in patients with hypertrophic cardiomyopathy (HCM Disease). Eligible patients have completed participation in REDWOOD-HCM or SEQUOIA-HCM.