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Study on Aficamten for Adults with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

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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 condition known as symptomatic non-obstructive hypertrophic cardiomyopathy. This is a heart condition where the heart muscle becomes thickened without blocking blood flow, which can lead to symptoms like shortness of breath and chest pain. The study will evaluate a medication called Aficamten, which is being compared to a placebo. Aficamten is a film-coated tablet developed by Cytokinetics Inc. and is also known by its code name CK-3773274.

The purpose of the study is to assess how Aficamten affects the health status and exercise capacity of participants with this heart condition. Participants will be randomly assigned to receive either Aficamten or a placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are unbiased. The trial will last for a period of 72 weeks, during which participants will undergo regular assessments to monitor their health and response to the treatment.

Throughout the study, participants will have their exercise capacity measured, which involves evaluating how well they can perform physical activities. The study will also monitor changes in their heart condition and overall health. The goal is to determine if Aficamten can improve symptoms and quality of life for those living with symptomatic non-obstructive hypertrophic cardiomyopathy. This research could potentially lead to new treatment options for individuals affected by this heart condition.

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 based on specific criteria such as age, body mass index, and medical history related to non-obstructive hypertrophic cardiomyopathy.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health status and exercise capacity. This includes measurements like the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and peak oxygen uptake (pVO2).

  3. Step 3

    Medication administration

    Participants receive either aficamten or a placebo. Aficamten is administered orally in the form of a 5 mg film-coated tablet. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Ongoing monitoring

    Throughout the study, regular monitoring of health status and exercise capacity is conducted. This includes tracking changes in KCCQ-CSS and pVO2 from baseline to Week 36.

  5. Step 5

    Secondary assessments

    Secondary assessments involve evaluating changes in various health parameters, such as NT-proBNP levels and left atrial volume index (LAVI), as well as monitoring for any cardiovascular events.

  6. Step 6

    Completion of study

    The study concludes with a final assessment to compare health status and exercise capacity from the beginning to the end of the trial period, which is estimated to last until April 2027.

Who can join the trial?

11 criteria

  • Age between 18 and 85 years at the time of screening.
  • Body mass index (BMI) less than 40 kg/m2. BMI is a measure of body fat based on height and weight.
  • Diagnosed with a condition called non-obstructive hypertrophic cardiomyopathy (nHCM). This is a heart condition where the heart muscle is thicker than normal.
  • Have a screening test called an echocardiogram showing specific heart measurements, such as:
    • Heart wall thickness of at least 15 mm in one or more areas, or at least 13 mm with a known gene mutation or family history of the condition.
    • Resting heart pressure (LVOT-G) less than 30 mmHg and Valsalva heart pressure less than 50 mmHg.
    • Heart's pumping ability (LVEF) of at least 60%.
    • Belong to New York Heart Association (NYHA) class II or III, which describes the level of heart failure symptoms.
    • Have a respiratory exchange ratio of at least 1.00 during a test called CPET, and a predicted peak oxygen uptake (pVO2) of 90% or less for their age and sex. This measures how well the body uses oxygen during exercise.
    • Have a KCCQ-CSS score between 30 and 85. This score measures the impact of heart failure on quality of life.
    • Have a N-terminal prohormone brain natriuretic peptide (NT-proBNP) level of at least 300 pg/mL, or 900 pg/mL if in atrial fibrillation or flutter. For Black participants, the levels are at least 225 pg/mL or 675 pg/mL if in atrial fibrillation or flutter. This is a blood test that helps assess heart function.
    • Hemoglobin level of at least 10 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.

Who cannot join the trial?

8 criteria

  • Having a different heart condition other than symptomatic non-obstructive hypertrophic cardiomyopathy. This is a heart problem where the heart muscle is thicker than normal, but it doesn't block blood flow.
  • Being outside the specified age range for the study.
  • Being part of a vulnerable population that the study is not designed to include.
  • Having any other medical condition that the study doctors think might make it unsafe to participate.
  • Taking medications or treatments that could interfere with the study results.
  • Being pregnant or planning to become pregnant during the study period.
  • Having a history of drug or alcohol abuse that could affect participation in the study.
  • Not being able to follow the study procedures or instructions.
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Investigated drugs

Aficamten is a medication being studied for its potential to help people with a heart condition called non-obstructive hypertrophic cardiomyopathy. This condition causes the heart muscle to thicken, which can make it harder for the heart to pump blood. Aficamten is being tested to see if it can improve the health and exercise capacity of people with this condition.

What is already known about the treatment

Aficamten – Aficamten is administered orally in tablet form. It is currently being studied in clinical trials, specifically in a Phase 3 trial, to assess its effectiveness and safety for treating adults with symptomatic non-obstructive hypertrophic cardiomyopathy. This medication works by modulating cardiac muscle contraction at the molecular level, aiming to improve heart function and exercise capacity. Aficamten is classified as a cardiac myosin inhibitor, which helps to reduce excessive heart muscle contraction, potentially alleviating symptoms associated with this condition.

Investigated diseases

Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy – This is a condition where the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. Unlike the obstructive form, there is no blockage of blood flow out of the heart. Symptoms can include shortness of breath, chest pain, and palpitations, especially during physical activity. The thickened heart muscle can lead to stiffness, reducing the heart's ability to fill with blood between beats. Over time, this can cause the heart to work harder to pump blood, potentially leading to heart failure. The progression of symptoms can vary widely among individuals, with some experiencing mild symptoms and others more severe.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505797-15-00Protocol codeCY 6033Estimated enrolment435 patientsSponsorCytokinetics Inc.

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