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Study on the Long-Term Safety of Aficamten (CK-3773274) for Patients with Symptomatic Hypertrophic Cardiomyopathy

Verified siteInvestigationalNo 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 the effects of a medication called Aficamten (also known by its code name CK-3773274) in patients with a heart condition known as Hypertrophic Cardiomyopathy (HCM). HCM is a disease where the heart muscle becomes abnormally thick, which can make it harder for the heart to pump blood. The purpose of this study is to gather information on the long-term safety and how well patients tolerate Aficamten when used to treat symptoms of HCM.

Participants in the study will take Aficamten in the form of a film-coated tablet, which is taken orally. The study will monitor patients over a period to observe any side effects or changes in their condition. The study aims to ensure that Aficamten is safe for long-term use and to understand how it affects the heart's function in people with HCM. The study will also compare the effects of Aficamten with a placebo to determine its effectiveness.

Throughout the study, researchers will keep track of any adverse events, which are any unwanted effects that occur during the trial. They will also monitor the heart's performance, specifically looking at the heart's ability to pump blood effectively. This will help determine if Aficamten can be a safe and effective treatment option for people living with symptomatic HCM. The study is designed to provide valuable insights into the management of this heart condition and improve treatment options for patients in the future.

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

    Joining the study

    Upon joining the study, the patient will begin treatment with aficamten, a medication used to manage symptoms of hypertrophic cardiomyopathy (HCM).

    The medication is administered in the form of a film-coated tablet and is taken orally.

  2. Step 2

    Medication administration

    The patient will take aficamten as prescribed by the study protocol. The specific dosage and frequency will be determined by the study team based on individual needs and responses.

    The treatment is designed to be long-term, with regular monitoring to assess safety and tolerability.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor the effects of the medication. This includes checking for any adverse events and measuring heart function.

    Key assessments include monitoring the left ventricular ejection fraction (LVEF) and left ventricular outflow tract gradient (LVOT-G) at rest and during specific maneuvers.

  4. Step 4

    Follow-up evaluations

    The patient will have follow-up evaluations at 12-week intervals to assess changes from baseline measurements.

    These evaluations will help determine the effectiveness of the treatment and any necessary adjustments to the medication regimen.

  5. Step 5

    Completion of study participation

    The study is expected to continue until June 2026, with the patient participating for the duration specified in the study protocol.

    Upon completion, the patient will undergo a final assessment to evaluate the overall impact of the treatment.

Who can join the trial?

6 criteria

  • The patient must understand and be willing to sign a consent form and follow all study procedures and rules for the entire study period.
  • The patient should have completed a previous study involving the drug CK-3773274. If they couldn't complete it due to reasons not related to following rules or safety, a medical expert will decide if they can join.
  • The patient must have a left ventricular ejection fraction (LVEF) of 55% or higher. This is a measure of how well the heart pumps blood.
  • Male patients must agree to not donate sperm during the study and for at least 10 weeks after the last dose of the study drug. They must also either not have heterosexual intercourse or use a condom and ensure their female partner uses a highly effective birth control method during the study and for 4 weeks after the last dose.
  • Female patients must not be pregnant, breastfeeding, or planning to donate eggs. They must either not be able to become pregnant or, if they can become pregnant, use a highly effective birth control method and have their male partner use a condom during the study and for 4 weeks after the last dose. They must also have a negative pregnancy test before starting the study drug.
  • The patient must be willing and able to complete all initial screening tests.

Who cannot join the trial?

8 criteria

  • Patients who have other serious heart conditions besides hypertrophic cardiomyopathy (HCM), which is a condition where the heart muscle becomes thickened.
  • Patients who have had a heart attack or heart surgery in the past three months.
  • Patients with uncontrolled high blood pressure, meaning their blood pressure is not well-managed with medication or lifestyle changes.
  • Patients with severe liver or kidney disease, which means their liver or kidneys are not working properly.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for the baby.
  • Patients who are participating in another clinical trial, as this could affect the results of the study.
  • Patients who have a history of drug or alcohol abuse, which means they have used drugs or alcohol in a way that is harmful to their health.
  • Patients who have a known allergy to the study medication or any of its ingredients.
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Investigated drugs

Aficamten (CK-3773274) is a medication being studied for its effects on patients with hypertrophic cardiomyopathy (HCM), a condition where the heart muscle becomes abnormally thick. This medication is being evaluated to see if it is safe and well-tolerated by patients who have symptoms of HCM. The goal is to understand how this treatment can help manage the condition over a sustained period.

What is already known about the treatment

Aficamten – Aficamten is administered orally in the form of tablets. It is currently being studied in clinical trials for its safety and tolerability in treating symptomatic hypertrophic cardiomyopathy (HCM). The medication is primarily indicated for patients with HCM, a condition characterized by thickened heart muscle. Aficamten works by selectively inhibiting cardiac myosin, which helps reduce the excessive contraction of the heart muscle, thereby improving heart function. It is classified as a cardiac myosin inhibitor in pharmacology.

Investigated diseases

Hypertrophic Cardiomyopathy – Hypertrophic cardiomyopathy (HCM) is a condition where the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. This thickening can occur in different parts of the heart, but it most commonly affects the septum, the wall that separates the left and right sides of the heart. As the heart muscle thickens, it can lead to problems with the heart's electrical system, potentially causing irregular heartbeats. Over time, the thickened heart muscle can also lead to stiffness, reducing the heart's ability to fill with blood. Symptoms may include chest pain, shortness of breath, and fainting, especially during physical activity. The progression of the disease can vary widely among individuals, with some experiencing mild symptoms and others facing more significant challenges.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508963-58-00Protocol codeCY 6022Estimated enrolment896 patientsSponsorCytokinetics Inc.

sourced from the EU Clinical Trials Register and site verification

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