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 study about?

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).

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Ccykuc Hjodvqgidmi Ugytlvxfzjoku Dj Degws	Dijon	France
Awarxxhlvw Pkrhfzrj Hrscjqeg Dj Mypeenxim	Marseille	France
Ciopar Haiskvgmboc Rydyxeto Uaoqjlccttiyt Ds Tvcbc	Tours	France
Cimf Dg Nicqk	Vandoeuvre Les Nancy	France
Carqoc Hfebexpbmnv Rpjpgnla Dnragiwjxxlnva	Angers	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.09.2025

Trial locations

Investigated drugs:

Rivaroxaban

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.

Investigated diseases:

Hypertrophic cardiomyopathy

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 ID:

2024-511084-28-00

Protocol code:

2024-511084-28

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?