RecruitingPhase 3NCT07202897

LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain.

LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain: A Randomized Multicenter Trial


Sponsor

Rennes University Hospital

Enrollment

532 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Hypertrophic cardiomyopathy (HCM) is a common (\> 1/500 in the general adult population) genetically transmitted disease impacting markedly patients' lives from the early ages to the latest. The phenotype as the prognosis of HCM may greatly differ from one patient to another: most patients present no or few symptoms and a near-normal lifespan, while others are severely symptomatic. Paroxysmal, persistent or permanent atrial fibrillation (AF) is frequent in HCM, occurring in more than 20%-25% of patients and is often considered as an important turning point for the quality of life of these patients. AF decreases cardiac output and exercise tolerance, increases hospitalization rate, and markedly increase the risk of embolic stroke with the need for life-anticoagulation. It has been shown that stroke may precede AF discovery and that it may occur at young ages with devastation consequences. AF also may trigger sudden cardiac death. Observational studies have been conducted to search for parameters which correlate with the risk of AF (P wave duration and supra-ventricular burst on the Holter-ECG monitoring, L-wave morphology, degree of hypertrophy, clinical parameters-comorbidities, and size of the left atrium) with no real impact on clinical management. Left Atrial strain (LA-strain) has been recently demonstrated relevant (for instance our pilot work (for predicting stroke and/or AF (a cut-off of 15% is highly specific, 20% being the optimal cut-off). LA-strain (cut-off 20%) could be used for defining the patients that might require preventive anticoagulation therapy. A randomized clinical trial is needed to extend the use of anticoagulation therapy to patients in sinus rhythm but identified to be at risk for AF. Of note, it has been demonstrated that in this population, stroke occurred in 67% of the patients without any clinical atrial arrhythmia.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anticoagulant treatment Rivaroxaban and Best medical therapy for people with hypertrophic cardiomyopathy (hcm). The study is currently recruiting participants at 17 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAnticoagulant treatment Rivaroxaban

Anticoagulant treatment Rivaroxaban in addition to best medical therapy

OTHERBest medical therapy

Best medical therapy alone


Locations(17)

CHU Angers

Angers, France

CHU Bordeaux Haut-Levêque

Bordeaux, France

CHU Brest - Hôpital La Cavale Blanche

Brest, France

CHU Caen

Caen, France

CHU Dijon - Hôpital François Mitterrand

Dijon, France

CHU Grenoble Alpes

Grenoble, France

CHU Lille

Lille, France

APHM - Hôpital La Timone

Marseille, France

CHU de Nantes -Hôpital Nord Laennec

Nantes, France

AP-HP Höpital la Pitié-Salpétrière

Paris, France

APHP Hopital Européen Georges Pompidou

Paris, France

APHP, Hôpital Lariboisière

Paris, France

CHU Rennes - Hôpital Pontchaillou

Rennes, France

CHU de Rouen

Rouen, France

CHU Rangueil Toulouse

Toulouse, France

CHU de TOURS - HOPITAL TROUSSEAU

Tours, France

CHU Nancy

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07202897


Related Trials