LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Pa
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 an
| Condition(s) | Hypertrophic Cardiomyopathy (HCM) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 tha |
| Who can participate | Inclusion Criteria: 1. 40 - 80 years of age 2. 50 and 120 kg of weight 3. In sinus rhythm 4. Prior confirmed diagnosis of "primary" hypertrophic cardiomyopathy 5. Left Atrial reservoir strain measured ≤20% (corelab confirmation) 6. Signature of an informed consent 7. 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 Exclusion Criteria: 1. Secondary hypertrophic cardiomyopathy (aortic stenosis, hypertension, amyloidosis and all phenocopies…) 2. Signs of heart failure 3. Hospitalization 4. Uncontrolled blood pressure 5. Creatinine clearance \<30 mL/min (Cockcroft) 6. Severe liver dysfunction, cirrhosis Child B or C |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Lead sponsor | Rennes University Hospital |
| Locations | Angers, France; Bordeaux, France; Brest, France; Caen, France; Dijon, France; Grenoble, France (+11 more sites) |
| Start date | 2026-01-07 |
| NCT ID | NCT07202897 |
| Official listing | https://clinicaltrials.gov/study/NCT07202897 |