MAPLE-HCM

A Clinical Trial Evaluating an Investigational Drug for Obstructive Hypertrophic Cardiomyopathy (oHCM) 

 

About oHCM

WHAT IS OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (oHCM)?

Hypertrophic cardiomyopathy (HCM) is a chronic heart disease in which the abnormally thickened (hypertrophied) heart muscle (myocardium) prevents the heart from pumping blood efficiently (cardiomyopathy).  

Obstructive hypertrophic cardiomyopathy (oHCM) is a condition that may occur in people who have HCM. Obstructive HCM is a condition in which the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart, and the heart muscle works harder to pump blood to the body (increased heart pumping function).

Patients diagnosed with oHCM may not exhibit symptoms in the early stages of the condition but may develop them over time, including signs and symptoms that can disrupt daily life, such as:

  • Chest Pain

  • Dizziness

  • Shortness of breath

  • Fainting

The severity of these symptoms varies widely between people with oHCM and can even vary day-to-day. 

About MAPLE-HCM

A Clinical Research Trial

The purpose of this study is to compare the side effects and effectiveness of aficamten with the beta-blocker, metoprolol succinate (metoprolol), in participants with obstructive hypertrophic cardiomyopathy (oHCM). The effectiveness of both medicines will be compared by measuring your ability to exercise, heart failure symptoms, and the structure of your heart by taking an echocardiogram (pictures of your heart taken outside your body).

Participants will be randomly assigned to receive either metoprolol or aficamten.

Aficamten is the investigational medicine being studied in this trial. In oHCM the heart muscle works harder to pump blood to the body. Aficamten may reduce symptoms of oHCM by reducing the strength of pumping in the heart muscle.

Abbreviated Participation Criteria:

  • 18 to 85 years old

  • Body mass index < 35 kg/m2

  • Able to swallow whole tablets

  • If you still have symptoms related to your heart condition even though you are on certain medications.

  • Regardless of whether or not you have received medication for your oHCM, such as beta-blockers or calcium channel blockers.


    Additional participation criteria will apply. Full details regarding the participation criteria can be found at https://clinicaltrials.gov (NCT05767346).

Clinical Trial Participation Period:
Now and ongoing.

What is
MAPLE-HCM?

Clinical Trial Overview:

MAPLE-HCM is a phase 3 clinical trial of aficamten compared to Metoprolol in patients with symptomatic obstructive hypertrophic cardiomyopathy.

The 24 weeks of the clinical trial will compare effectiveness of both medicines by measuring ability to exercise, heart failure symptoms, and the heart structure by taking an echocardiogram (pictures of the heart taken outside the body). The study will also measure the amount of aficamten in the blood at various times, and the effect the research medicine may have on oHCM.

Clinical Trial Duration:

The clinical trial participation will be over a 24-week period. It will include a screening, trial treatment, and a follow-up period for all trial participants.

Clinical Trial Drug:

If the study doctor determines a patient is eligible and the patient agrees to participate, they will receive either aficamten or metoprolol during the treatment period (but not both) for a total of 24 weeks (a 6-month period). To be sure that the patient, thestudy doctor, and the study staff do not know which study medicine the patient receives, the patient will also take placebo tablets. Placebo are identical in appearance to the study medicine, but contain no active ingredient.

STUDY MEDICINE DOSES

  • Aficamten (5, 10, 15, or 20 mg) and placebo for metoprolol

OR

  • Metoprolol (50, 100, 150, or 200 mg) and placebo for aficamten

The study medicine the patient receives will be determined by chance (like flipping a coin). The chance of receiving aficamten will be 1/2 (50%) and the chance of receiving metoprolol will be 1/2 (50%).

Clinical Trial Locations

Clinical trial sites for MAPLE-HCM are recruiting trial participants across the United States.

MAPLE-HCM Site Locations:

Visit clinicaltrials.gov (NCT05767346) to view contacts & locations.