Study of Spironolactone to Reduce Right Ventricle Damage and Heart Rhythm Problems in Adults With Arrhythmogenic Right Ventricular Dysplasia

What this Trial Is About

Researchers are studying arrhythmogenic right ventricular dysplasia ARVD, a rare heart condition where fat and fibrous tissue replace heart muscle in the right ventricle, causing electrical instability and abnormal heart rhythms. Current treatments focus only on controlling arrhythmias, and this trial aims to evaluate if spironolactone, a potassium-sparing diuretic, can reduce the worsening of right ventricular function and arrhythmia burden in ARVD patients. This is a phase II randomized, double-blind study conducted at multiple centers in France. Participants will be randomly assigned to receive either spironolactone at a dose of 25 mg per day or a placebo for 12 months. The study includes two groups one receiving spironolactone and the other receiving placebo, with 60 patients per group. Patients will be followed for up to 3 years with scheduled examinations including ECG, 24-hour Holter monitoring, transthoracic echocardiography, and biological tests according to standard care. During the study, patients will undergo evaluations at 6 months, 1 year, and 3 years to assess heart function, arrhythmia events, and various biological markers. Researchers will measure right ventricle strain, ventricular extrasystoles, and other heart function parameters using echocardiography and ECG. The study also monitors hospital admissions and symptoms such as palpitations, dyspnea, and syncope. Safety and effectiveness will be carefully observed throughout the trial period ending in 2029.

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