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Myosin Inhibitor

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

Phase 3

Waitlist Available

Research Sponsored by Cytokinetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with oHCM per the specified criteria by cardiac magnetic resonance imaging (CMR) or echocardiography

Males and females between 18 to 85 years of age, inclusive, at screening

Must not have

Planned septal reduction treatment that cannot be deferred during the trial period

History of paroxysmal or persistent atrial fibrillation or atrial flutter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 24

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include changes in blood pressure or heart rate, dizziness due to low blood pressure, fatigue, disturbances in heartbeat rhythm (arrhythmias), and possibly other cardiovascular-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 85 years old.

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My heart condition mildly or moderately affects my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a history of irregular heartbeats.

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I have a condition that causes thickening of the heart muscle, similar to oHCM.

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I have a serious heart valve condition.

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I cannot tolerate or am medically advised against beta blocker medications.

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I have had fainting spells or dangerous heart rhythms during exercise in the last 6 months.

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I have had heart muscle weakness or stress-related heart issues.

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I have been treated with aficamten or could not tolerate mavacamten.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in peak oxygen uptake (pVO2) by cardiopulmonary exercise testing (CPET)

Secondary study objectives

Change from baseline values in NT-proBNP from baseline to Week 24

Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)

Change in left atrial volume index (LAVI)

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 11Eligibility criteria met