Informations générales (source: ClinicalTrials.gov)
Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD: a Double-blind Multicentre Prospective Randomized Study. (BRAVE)
Interventional
Phase 2
Hospices Civils de Lyon (Voir sur ClinicalTrials)
décembre 2024
décembre 2029
17 mai 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Amiens Picardie - Amiens - France | Maciej KUBALA, Dr | Contact (sur clinicalTrials) | |||
| CHU Dijon - Dijon - France | Gabriel Laurent, Dr | Contact (sur clinicalTrials) | |||
| Groupe Hospitalo Universitaire Caremeau - Nimes - France | Pierre-François WINUM, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Arnaud de Villeneuve - Montpellier - France | François ROUBILLE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Cardiologique Louis Pradel - Bron - France | Philippe Chevalier, Pr | Contact (sur clinicalTrials) | |||
| Hôpital de Haut-Lévêque - Pessac - France | Frédéric SACHER, Dr | Contact (sur clinicalTrials) | |||
| Hôpital de la Timone - Marseille - France | Jerome HOURDAIN, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Gabriel Montpied - Clermont-ferrand - France | Gregoire MASSOULIE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Laennec - Nantes - France | Vincent PROBST, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Michallon - Grenoble - France | Pascal DEFAYE, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Pitié Salpetrière - Paris - France | Estelle GANDJBAKHCH, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Rangueil - Toulouse - France | Philippe MAURY, Pr | Contact (sur clinicalTrials) | |||
| Nouvel Hôpital Civil - Strasbourg - France | Laurence JESEL-MOREL, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- >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.
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: 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.