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Study on Mavacamten for Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a heart condition called Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM). This condition involves the thickening of the heart muscle, which can make it harder for the heart to pump blood. The study will use a treatment called Mavacamten, which is taken as a capsule. Mavacamten is being tested to see if it can help reduce the thickness of the heart wall and the size of the upper heart chamber, known as the atria. The study will use a special imaging technique called Cardiac Magnetic Resonance (CMR) to look at changes in the heart's structure.

The purpose of this study is to determine if Mavacamten can effectively reduce the thickness of the heart wall and the size of the atria in patients with oHCM. Participants in the study will be randomly assigned to receive either Mavacamten or a placebo, which is a capsule that looks like the medication but does not contain the active ingredient. The study will last for a period of 96 weeks, during which participants will have regular check-ups and imaging tests to monitor their heart condition.

Throughout the study, the impact of Mavacamten on heart function will be assessed, including any improvements in symptoms related to heart failure. The study will also monitor for any other heart-related events to ensure the safety of the treatment. The goal is to see if Mavacamten can provide a beneficial effect on the heart's structure and function in people with oHCM.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), classified as New York Heart Association (NYHA) Functional Class II or III.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes imaging studies using cardiac magnetic resonance (CMR) to evaluate heart wall thickness and the size of the upper heart chamber (atria).

  3. Step 3

    Medication administration

    Participants receive either mavacamten or a placebo. Mavacamten is administered in capsule form, taken orally. The dosage and frequency are determined by the study protocol.

  4. Step 4

    Ongoing monitoring

    Throughout the study, regular monitoring is conducted to assess the impact of the treatment. This includes evaluating changes in heart wall thickness and upper chamber size using CMR at specified intervals.

  5. Step 5

    Evaluation of heart failure class

    The study also evaluates the improvement in heart failure class for participants with symptomatic oHCM, as well as monitoring for any other cardiac events as part of a safety assessment.

  6. Step 6

    Final assessment

    At week 48, a final assessment is conducted to evaluate the efficacy of mavacamten on reducing heart wall thickness and upper chamber size, as well as any improvements in heart failure class.

Who can join the trial?

4 criteria

  • Adults with **symptomatic obstructive hypertrophic cardiomyopathy** can participate. This is a condition where the heart muscle becomes thick, making it harder for the heart to pump blood.
  • Participants should be in **NYHA Functional Class II or III**. This means they have some limitations in physical activity due to their heart condition, but they are comfortable at rest.
  • Both **men and women** are eligible to join the study.
  • The study is open to individuals who are considered part of a **vulnerable population**. This term refers to groups who may need special protection or care.

Who cannot join the trial?

12 criteria

  • Patients who have other serious heart conditions besides the one being studied.
  • Patients who have had a heart attack in the past 6 months.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication.
  • Patients who have a pacemaker or other implanted heart device.
  • Patients who have had heart surgery in the past 3 months.
  • Patients with certain types of irregular heartbeats.
  • Patients who are unable to undergo imaging studies, like MRI, due to medical reasons.
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Investigated drugs

Mavacamten is a medication being studied to see if it can reduce the thickness of the heart wall and the size of the upper heart chamber in adults with symptomatic obstructive hypertrophic cardiomyopathy. This condition causes the heart muscle to thicken, which can make it harder for the heart to pump blood. The study uses cardiac magnetic resonance imaging (CMR) to assess changes in the heart's structure while using this medication.

What is already known about the treatment

Mavacamten – Mavacamten is administered orally in the form of a capsule. It is currently being studied in clinical trials for its effectiveness in treating symptomatic obstructive hypertrophic cardiomyopathy, a condition where the heart muscle becomes abnormally thick. The medication works by inhibiting cardiac myosin, a protein involved in heart muscle contraction, which helps to reduce the thickness of the heart wall and the size of the upper heart chamber. Mavacamten is classified as a cardiac myosin inhibitor and is being evaluated for its potential to improve heart function and symptoms in affected individuals.

Investigated diseases

Symptomatic Obstructive Hypertrophic Cardiomyopathy – This is a condition where the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. The thickening often occurs in the septum, the wall dividing the left and right sides of the heart, which can obstruct blood flow from the left ventricle to the aorta. Symptoms may include chest pain, shortness of breath, and palpitations, especially during physical activity. Over time, the heart's ability to pump blood effectively can be compromised, leading to symptoms of heart failure. The condition can also cause irregular heartbeats, which may be felt as fluttering or pounding in the chest. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing more severe challenges.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502316-36-00Protocol codeCV0271088Estimated enrolment175 patientsSponsorMyokardia Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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