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Study Evaluating Direct Oral Anticoagulants for Prevention of Blood Clots in Patients with Hypertrophic Cardiomyopathy and Abnormal Left Atrial Function

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What is this trial about?

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

This study focuses on Hypertrophic Cardiomyopathy, a condition where the heart muscle thickens, making it harder for the heart to pump blood. Patients with this condition sometimes have an abnormal Left Atrial Reservoir Strain (a measurement of how well a specific chamber of the heart stretches and functions), which may increase the risk of blood clots forming. The research aims to determine if using anticoagulant medication (blood thinners) is better than standard care in preventing complications in these patients.

The study will evaluate how well direct oral anticoagulants work in preventing serious events like stroke, myocardial infarction (heart attack), and systemic embolism (blood clots traveling to other parts of the body) in people with Hypertrophic Cardiomyopathy who have reduced heart chamber function. Participants will be monitored through various tests, including ECG (electrocardiogram) and Holter monitoring (a portable device that records heart rhythm).

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

    Randomization

    After joining the LA-HCM study, you will be randomly assigned to one of two groups: either the treatment group receiving rivaroxaban (a direct oral anticoagulant) or the control group receiving standard management.

    This randomization process ensures that the results of the study will be scientifically valid.

  2. Step 2

    Treatment Period

    If assigned to the treatment group, you will take rivaroxaban tablets daily. The medication will be provided as either 15 mg or 20 mg film-coated tablets.

    The treatment period will continue for the duration of the study, which is expected to run until September 15, 2025.

    You will need to take the medication exactly as prescribed by your doctor.

  3. Step 3

    Regular Follow-up Visits

    Throughout the study, you will attend scheduled follow-up visits at the clinic.

    During these visits, the medical team will monitor your health and perform various tests to evaluate how you are responding to the treatment.

    Tests will include ECG/Holter monitoring (recordings of your heart's electrical activity), assessment of your Left Atrial Reservoir Strain (a measurement of how well a specific chamber of your heart is functioning), and other heart-related examinations.

  4. Step 4

    Quality of Life Assessment

    As part of the study, you will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ).

    This questionnaire helps assess how your heart condition affects your daily life and overall well-being.

    Your responses will provide important information about the impact of the treatment on your quality of life.

  5. Step 5

    Monitoring for Events

    Throughout the study, the medical team will monitor you for any ischemic events (such as heart attack, stroke, or blood clots) and bleeding events.

    If you experience any unusual symptoms or health concerns during the study, you should report them promptly to the study team.

    Some participants may undergo magnetic resonance imaging (MRI) to check for any asymptomatic (without symptoms) stroke events.

  6. Step 6

    Study Completion

    The study is scheduled to conclude on September 15, 2025.

    At the end of the study, your doctor will discuss the next steps for your care.

    The findings will help determine if anticoagulant treatment is beneficial for patients with hypertrophic cardiomyopathy (a condition where the heart muscle becomes abnormally thick) who have reduced left atrial reservoir strain (a measurement of heart function).

Who can join the trial?

5 criteria

  • Age between 18 and 80 years
  • Having a normal heart rhythm (sinus rhythm)
  • Previously diagnosed with primary hypertrophic cardiomyopathy (a condition where the heart muscle becomes abnormally thick)
  • Having an abnormal Left Atrial Reservoir Strain measured at ≤20% (this is a measurement of how well a specific chamber of your heart stretches and contracts, which will be confirmed by the study's central laboratory)
  • Willing and able to sign an informed consent form

Who cannot join the trial?

11 criteria

  • Previous heart attack or stroke in the last 6 months.
  • If you have severe heart valve disease (problems with the valves in your heart that control blood flow).
  • If you have had a blood clot in your heart.
  • If you have a disease that causes increased risk of bleeding.
  • If you are allergic to the study medication.
  • If you have severe liver disease (the liver is an organ that processes nutrients and filters toxins from your blood).
  • If you have severe kidney disease (kidneys filter waste from your blood).
  • If you are currently participating in another clinical trial.
  • If you are pregnant or breastfeeding.
  • If you have a history of non-compliance with medical treatments (not following doctor's instructions regularly).
  • If you have a life expectancy of less than 1 year due to other medical conditions.
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Investigated drugs

  • Edoxaban

    is a medication used to prevent blood clots. It belongs to a group of medicines called direct oral anticoagulants (DOACs). In this study, it's being tested to see if it can help prevent stroke and other problems caused by blood clots in people with a heart condition called hypertrophic cardiomyopathy.

  • Aspirin

    is a common medication that helps prevent blood clots by making platelets in your blood less sticky. It's often used to reduce the risk of heart attacks and strokes in people with certain heart conditions.

What is already known about the treatment

Direct oral anticoagulant (DOAC) – A type of blood-thinning medication that can be taken by mouth to prevent blood clots from forming in patients with hypertrophic cardiomyopathy. DOACs work by blocking specific proteins in the blood that are involved in the clotting process, helping to reduce the risk of stroke and other clot-related complications. These medications are considered an alternative to traditional blood thinners like warfarin, with potential advantages including fewer food-drug interactions and less need for regular blood monitoring. Currently, DOACs are being investigated for patients with hypertrophic cardiomyopathy who have abnormal left atrial function, as these patients may have a higher risk of developing dangerous blood clots.

Investigated diseases

Hypertrophic Cardiomyopathy – A genetic heart disease characterized by abnormal thickening of the heart muscle, particularly affecting the left ventricle. This thickening can make it harder for the heart to pump blood effectively and may cause the ventricle walls to become stiff. As the disease progresses, some patients develop obstruction to blood flow from the left ventricle, while others experience changes in the left atrium, including strain patterns and enlargement. Hypertrophic cardiomyopathy can lead to various complications including arrhythmias, particularly atrial fibrillation. Some patients remain asymptomatic for years, while others develop symptoms such as shortness of breath, chest pain, fatigue, palpitations, and occasionally dizziness or fainting.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-511084-28-00Protocol code2024-511084-28Estimated enrolment532 patientsSponsorCentre Hospitalier Universitaire De Rennes

sourced from the EU Clinical Trials Register and site verification

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