Long-term Safety of Aficamten for Hypertrophic Cardiomyopathy
(FOREST-HCM Trial)

Recruiting in Palo Alto (17 mi)

+88 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Cytokinetics

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is focused on collecting data about the safety and tolerability of a new medication called aficamten. The study involves people who are using this medication to see if it remains safe and well-tolerated over an extended period.

Eligibility Criteria

This trial is for individuals who have completed a previous Cytokinetics study with CK-3773274 and have a left ventricular ejection fraction (LVEF) of 55% or higher. It's not open to those who've had certain heart treatments, recent atrial fibrillation, or an investigational drug/device within the last month.

Inclusion Criteria

You have already taken part in a Cytokinetics study involving CK-3773274.

Your heart function is good, with a measurement of at least 55% at the screening visit.

Exclusion Criteria

I received a necessary shock from my defibrillator within the last 30 days.

I've had heart surgery or a procedure to reduce heart muscle thickness after my last CK-3773274 trial.

I recently developed a type of irregular heartbeat and started treatment for it less than 30 days ago.

+3 more

Participant Groups

The trial is focused on gathering long-term safety data for Aficamten (CK-3773274), which will be administered in doses ranging from 5 to 20 mg. This is an open-label study where all participants receive the drug.

1Treatment groups

Experimental Treatment

Group I: Aficamten up to 20 mgExperimental Treatment1 Intervention

Patients in this arm take daily dose of aficamten. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.