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Effect of oral mavacamten on left ventricular filling pressure in patients with hypertrophic cardiomyopathy

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on Hypertrophic cardiomyopathy, a condition where the heart muscle becomes unusually thick, making it harder for the heart to pump blood efficiently. Participants will receive the oral medication MAVACAMTEN (mavacamten), which belongs to a class of drugs known as myosin inhibitors. These drugs work by gently relaxing the heart muscle, helping to reduce the excessive thickness and improve blood flow.

The purpose of the study is to see whether MAVACAMTEN can lower the pressure measured as pulmonary capillary wedge pressure—a reading that reflects the pressure inside the lungs during physical activity. Volunteers will attend a series of visits where they will perform a simple exercise test on a bike while doctors monitor heart and lung pressures, blood oxygen levels, and overall exercise capacity. The study will follow each participant for several months, with assessments at the start, during the treatment period, and after the medication has been taken for a set time, allowing researchers to compare changes from the beginning to the end of the trial.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study Start

    After you have agreed to join the study, you will receive an overview of what will happen during the trial.

    You will be asked to confirm your participation by signing a consent form.

  2. Step 2

    Baseline Assessments

    You will undergo measurements of pulmonary capillary wedge pressure (the pressure in the lungs’ blood vessels) while you are at rest and while you exercise at a low workload of 25 watts.

    Additional tests will record heart rate, blood pressure, oxygen use, and other cardiovascular parameters to establish a starting point for comparison later in the study.

  3. Step 3

    Start of Medication

    You will begin taking the study drug mavacamten as an oral tablet.

    The prescribed dose is 15 mg taken once each day.

    You will continue this daily dose for the entire period you remain in the study.

  4. Step 4

    Ongoing Monitoring Visits

    At regular intervals you will return to the clinic for follow‑up visits.

    During each visit you will repeat the exercise test, again measuring pulmonary capillary wedge pressure at rest, at 25 W, at 50 % of your maximum workload, and at your maximum workload.

    The same set of cardiovascular and breathing measurements taken at baseline will be recorded again to track changes over time.

  5. Step 5

    Final Assessment

    At the end of the study you will have a final visit that includes the same series of measurements performed at baseline and during the follow‑up visits.

    These final results will be used to determine the overall effect of mavacamten on your heart’s pressure response to exercise.

Who can join the trial?

4 criteria

  • You must be at least 18 years old when you are screened for the study.
  • You must have a confirmed diagnosis of Hypertrophic cardiomyopathy (a condition where the heart muscle is unusually thick) that can be seen on heart imaging, and the thickest part of your heart muscle must be at least 15 mm thick (about the size of a small grain of rice).
  • Your heart symptoms must be rated as NYHA class II or higher. This means you have some limitation in everyday activities because of your heart condition (class I means no limitation, so you need a higher class).
  • Both men and women are allowed to participate in the trial.

Who cannot join the trial?

12 criteria

  • Phenocopies (conditions that look like hypertrophic cardiomyopathy but are actually other syndromes or metabolic disorders) are not allowed.
  • Changes to medicines that affect exercise ability or blood flow (such as diuretics, beta blockers, or calcium channel blockers) made within the last month, or planned changes, exclude participation.
  • Having had, or planning to have, a septal reduction therapy (a procedure to shrink part of the heart muscle) within the past three months excludes you.
  • Any health problem (for example, a psychiatric illness) or situation that the study doctor believes could make the study unsafe, difficult to follow, or affect the results will exclude you.
  • Having a LVEF (left ventricular ejection fraction, a measure of how well the heart pumps) below 50% is an exclusion.
  • Being treated with moderate to strong CYP2C19 or CYP3A4 inhibitors (medicines that change how other drugs are processed in the body) excludes participation.
  • A history of exercise‑induced syncope (fainting) within the last year is an exclusion.
  • Having severe angina (chest pain due to reduced blood flow to the heart) classified as Canadian Cardiovascular Society class III‑IV excludes you.
  • Having hemodynamically severe valvular disorders (serious problems with the heart valves that affect blood flow) is an exclusion.
  • Severe hypertension (high blood pressure) defined as systolic pressure over 200 mmHg or diastolic pressure over 110 mmHg excludes participation.
  • Inability to exercise because of orthopedic (bone or joint) problems or other non‑cardiovascular limitations excludes you.
  • Being pregnant or breastfeeding is an exclusion.
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Investigated drugs

MAVACAMTEN is an oral medication that works as a myosin inhibitor. It is being studied to see if it can lower the pressure in the left side of the heart during exercise for people who have hypertrophic cardiomyopathy, a condition where the heart muscle is unusually thick. By reducing the force of heart muscle contraction, the drug may help improve blood flow and reduce symptoms related to high heart pressure.

What is already known about the treatment

MAVACAMTEN - It is taken as an oral tablet, usually 15 mg, swallowed with water. The drug is already approved in the United States and Europe for treating hypertrophic cardiomyopathy and is well documented in medical literature. Its main use is to help patients with this heart condition by reducing the thickening of the heart muscle and improving how the heart fills with blood. Mavacamten works by selectively blocking the activity of cardiac myosin, which lessens the force of heart muscle contractions, and it is classified as a cardiac myosin inhibitor.

Investigated diseases

Hypertrophic cardiomyopathy - Hypertrophic cardiomyopathy is a condition in which the heart muscle becomes unusually thick, making it harder for the heart to fill with blood. The thickening can occur in different parts of the heart and may block the flow of blood (obstructive) or simply reduce the space for blood without a blockage (non‑obstructive). As the muscle thickens, the heart may work harder during physical activity, leading to higher pressures inside the heart chambers. Over time, the disease can cause the heart to become stiffer and less able to relax between beats. This progression often results in reduced exercise capacity and increased effort to maintain normal circulation.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-527595-90-00Estimated enrolment60 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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