Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
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.