Aficamten vs Metoprolol for Hypertrophic Cardiomyopathy
(MAPLE-HCM Trial)

Recruiting in Palo Alto (17 mi)

+70 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Cytokinetics

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial compares a new drug, aficamten, with a common heart medication, metoprolol succinate, in adults with a specific heart condition that causes symptoms and blood flow blockage. Aficamten helps the heart muscle relax, while metoprolol succinate slows and eases the heart's pumping. Metoprolol has been widely used since 1975.

Eligibility Criteria

Adults aged 18-85 with symptomatic hypertrophic cardiomyopathy and obstruction in the heart's left ventricle can join. They should have a BMI under 35, be class II or III for heart symptoms, and meet specific heart imaging criteria. Exclusions include high blood pressure at rest, certain other heart conditions, intolerance to beta blockers, recent severe arrhythmias or fainting episodes.

Inclusion Criteria

You need to have a specific type of heart test that shows certain results.

My heart condition was confirmed by a heart scan or ultrasound.

My heart condition mildly or moderately affects my daily activities.

+4 more

Exclusion Criteria

I am scheduled for a heart procedure that can't be postponed.

I have a history of irregular heartbeats.

I have taken disopyramide in the last 4 weeks.

+12 more

Participant Groups

The trial is testing Aficamten against Metoprolol Succinate to see which is better for adults with obstructive hypertrophic cardiomyopathy. Participants will receive varying doses of either drug or matching placebos to compare effectiveness and safety.

2Treatment groups

Experimental Treatment

Active Control

Group I: Aficamten up to 20 mg plus placebo for metoprololExperimental Treatment2 Interventions

Patients will receive doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten (CK-3773274) plus placebo for metoprolol succinate with dose levels guided by echocardiography assessments for up to 24 weeks.

Group II: Metoprolol succinate up to 200 mg plus placebo for aficamtenActive Control2 Interventions

Patients will receive 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten (CK-3773274) with dose levels guided by echocardiography and heart rate assessments for up to 24 weeks.