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Studies

Interventional Recruiting Phase 2

NCT03593317 on ClinicalTrials.gov

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

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

  • Sponsor: Hospices Civils de Lyon
  • Enrollment: 120 (Estimated)
  • Study start: 2024-12-20 (Actual)
  • Primary completion: 2027-12-01 (Estimated)
  • Study completion: 2029-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

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.

Conditions

  • Arrhythmogenic Right Ventricular Dysplasia

Intervention / Treatment

  • Drug: Spironolactone
  • Drug: Placebo

Primary Outcome Measures

  • Right ventricle longitudinal strain measured by echocardiography (at year 1)
  • Right ventricle infundibulum diameter measured by echocardiography (at year 1)
  • number of ventricular extrasystoles > 500 on 24h-Holter ECG (at year 1)

Countries

France

Locations and Investigators

  • Centre Hospitalier Universitaire De Nimes, Nimes, France
    • Pierre-François, Winum
  • University Hospital Of Montpellier, Montpellier Cedex 5, France
  • University Hospital Of Clermont-Ferrand, Clermont Ferrand Cedex 1, France
    • Gregoire, Massoulie
  • Centre Hospitalier Universitaire De Bordeaux, Pessac, France
  • Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 9, France
    • Philippe, Maury
  • Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
  • Hospices Civils De Lyon, Bron, France
  • Les Hopitaux Universitaires De Strasbourg, Strasbourg Cedex, France
    • Laurence, Jesel-Morel
  • Centre Hospitalier Universitaire De Nantes, Saint Herblain, France
  • Assistance Publique Hopitaux De Marseille, Marseille, France
    • Jerome, Hourdain
  • Centre Hospitalier Universitaire De Dijon, Dijon, France
    • Gabriel, Laurent
  • Assistance Publique Hopitaux De Paris, Paris, France
  • Centre Hospitalier Universitaire Amiens Picardie, Amiens, France
    • Maciej, KUBALA

Study Officials