• Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-angiotensin-aldosterone System

  NCT02010905

  Unknown statusInterventionalPhase 2Updated Dec 22, 2015
• Aldosterone Blockade in Heart Failure

  NCT00523757

  CompletedInterventionalPhase 3Updated Nov 7, 2018
• Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study

  NCT03315832

  WithdrawnInterventionalPhase 2Phase 3Updated Mar 17, 2023
• Spironolactone Therapy in Chronic Stable Right HF Trial

  NCT03344159

  CompletedInterventionalPhase 4Updated May 6, 2026
• Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial

  NCT02169089

  CompletedInterventionalPhase 4Updated Aug 1, 2023
• Inhibition of Aldosterone to Reduce Myocardial Diffuse Fibrosis in Patients With Paroxysmal and Persistent Atrial Fibrillation in Preventing Recurrent Episodes of Atrial Fibrillation

  NCT02764619

  Unknown statusInterventionalPhase 3Updated May 17, 2016

ClinicalTrials.gov ID

NCT03593317

Lead Sponsor

Hospices Civils de LyonOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

120Estimated

Last Update Posted

Feb 9, 2026Actual

Start Date

Dec 20, 2024Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2029Estimated

Official Title

Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD: a Double-blind Multicentre Prospective Randomized Study.

Brief 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. 13 centers in France will enroll the 120 patients (60 per group). Patients will be followed for 3 years (6 months, 1 year and 3 years) with all examinations (ECG, HA ECG, 24-hour Holter, trans-thoraciqc echocardiography (TTE), biological analyses) according to standard of care. 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.

• Arrhythmogenic Right Ventricular Dysplasia

• Spironolactone
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.
• Left Ventricular Ejection Fraction >40%
• Written informed consent.

Exclusion Criteria:

• Patients under judicial protection.
• 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: anuria, hyperkalemia (K+>5 mmol/l), renal failure (DFGCréat>22 mL/min/1,73 m2), end-stage liver failure, Addison's Disease, hypersensitivity to spironolactone or to any of the excipients (patients with galactose intolerance, lapp lactase deficiency or glucose or galactose malabsorption syndrome), association with eplerenone, association with other hyperkalemic diuretics, association with potassium salts, not recommended in cirrhotic patients (natraemia<125 mmol/l) or in patients likely to present an acidosis.
• 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.
• Normal right ventricular volume.
• Heart transplantation.
• Swallowing disorders.
• Participation in any other interventional clinical investigation that may have an impact on our study.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Hospices Civils de LyonOTHER

gabriel.laurent@chu-dijon.fr+33 380 293 536