Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Arrhythmogenic right ventricular dysplasia (ARVD) is a rare cardiomyopathy characterized by the progressive replacement of cardiomyocytes by fatty and fibrous tissue in the right ventricle (RV). These infiltrations lead to cardiac electrical instability and ventricular arrhythmia.

Current treatment for ARVD is empirical and essentially based on treatment of arrhythmia. Thus, there is no validated treatment that will prevent the deterioration of the RV function in patients with ARVD.

The investigator's hypothesis is that the use of anti-fibrotic medications will prevent or at least reduce the deterioration of the RV function. The aim of this project is to evaluate the effect of spironolactone, a Potassium-sparing diuretic on ventricular myocardial remodeling and on arrhythmia burden in patients with ARVD.

The trial is a double-blind parallel multicenter prospective randomized phase II drug study. Patients will be randomized in the two groups: spironolactone or placebo. 19 centers in France will enroll the 120 patients (60 per group). Patients will be followed up every 6 months for 3 years. A decrease in right and/or left ventricular deterioration and in arrhythmia burden are expected in ARVD patients treated with spironolactone. This reduction will improve the quality of life of patients and will reduce the number of hospitalizations and the risk of terminal heart failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Ramipril; Spironolactone

Criteria

Inclusion Criteria:

• >18years old

• 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)

• Left Ventricular Ejection Fraction >40%

• Written informed consent.

Exclusion Criteria:

• Pregnancy.

• No health insurance.

• MRI contraindication (claustrophobia, implantable defibrillator).

• Right heart failure patient (RV volume>150ml)

• Spironolactone contraindication (hypotension, renal failure).

• Normal right ventricular volume

• Heart transplantation

• Swallowing disorders