BLOCKADE OF THE RENIN-ANGIOTENSIN-ALDOSTERONE SYSTEM IN PATIENTS WITH ARVD.BRAVE
- Conditions
- Arrhythmogenic right ventricular dysplasiaMedDRA version: 20.1Level: PTClassification code: 10058093Term: Arrhythmogenic right ventricular dysplasia Class: 100000004850Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-505048-20-00
- Lead Sponsor
- Hospices Civils De Lyon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Adult patient= 18 years, Diagnosis of ARVD based on Task Force criteria. Two major criteria: 1 morphologic and one rhythmic or 1 major and 2 minor criteria established by the European Society of Cardiology/International Society and Federation of Cardiology, Increased right ventricular volume (> 100ml/m² female; > 110ml/m² male)., LVEF >40%, Signed written informed consent
Patients under judicial protection, Normal right ventricular volume, Heart transplantation, Swallowing disorders, Participation in any other interventional clinical investigation that may have an impact on our study, Female patient who is pregnant or lactating, or is of child bearing potential (defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if = 55 years or 12 months if > 55 years) and who did not agree to use highly effective methods of birth control throughout the study., No health insurance, Right heart failure patient (RV volume>150ml), Spironolactone contraindication, Mandatory indication for a combination of ACE inhibitor and sartan or renin inhibitor (each authorized separately), Acute phase of systemic disease, Uncompensated hypothyroidism, Acute hyperthyroidism
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method