Atrial Fibrillation Clinical Trials

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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 40 - 80 years of age

• 50 and 120 kg of weight

• In sinus rhythm

• Prior confirmed diagnosis of primary hypertrophic cardiomyopathy

• Left Atrial reservoir strain measured ≤20% (corelab confirmation)

• Signature of an informed consent

• Highly effective contraceptive methods for women of childbearing potential from at least 14 days prior to start treatment, throughout the study treatment period, and until at least 4 weeks after the last dose of study medication

Locations
Other Locations
France
CHU Angers
NOT_YET_RECRUITING
Angers
CHU Bordeaux Haut-Levêque
NOT_YET_RECRUITING
Bordeaux
CHU Brest - Hôpital La Cavale Blanche
NOT_YET_RECRUITING
Brest
CHU Caen
NOT_YET_RECRUITING
Caen
CHU Dijon - Hôpital François Mitterrand
RECRUITING
Dijon
CHU Grenoble Alpes
NOT_YET_RECRUITING
Grenoble
CHU Lille
NOT_YET_RECRUITING
Lille
APHM - Hôpital La Timone
NOT_YET_RECRUITING
Marseille
CHU de Nantes -Hôpital Nord Laennec
NOT_YET_RECRUITING
Nantes
AP-HP Höpital la Pitié-Salpétrière
NOT_YET_RECRUITING
Paris
APHP Hopital Européen Georges Pompidou
NOT_YET_RECRUITING
Paris
APHP, Hôpital Lariboisière
NOT_YET_RECRUITING
Paris
CHU Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
CHU de Rouen
NOT_YET_RECRUITING
Rouen
CHU Rangueil Toulouse
NOT_YET_RECRUITING
Toulouse
CHU de TOURS - HOPITAL TROUSSEAU
NOT_YET_RECRUITING
Tours
CHU Nancy
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Courpron Julie
dri@chu-rennes.fr
02 99 28 25 55
Backup
ganivet anne
anne.ganivet@chu-rennes.fr
Time Frame
Start Date: 2026-01-07
Estimated Completion Date: 2033-01-07
Participants
Target number of participants: 532
Treatments
Experimental: Anticoagulant treatment Rivaroxaban
Active_comparator: Best medical therapy
Sponsors
Leads: Rennes University Hospital

This content was sourced from clinicaltrials.gov