NCT03593317RecruitingPhase 2
Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD
Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD: a Double-blind Multicentre Prospective Randomized Study.
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 10 Jul 2018
- Start date
- 20 Dec 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Heart failure
- NCT number
- NCT03593317
- EU CT number
- 2023-505048-20-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 20 Dec 2024 to the primary completion date, Dec 2027
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Mandatory indication for a combination of ACE inhibitor and sartan or renin inhibitor (each authorized separately).
Other illness
- Right heart failure patient (RV volume\>150ml).
- Acute phase of systemic disease.
- Heart transplantation.
- Swallowing disorders.
Lab values
- 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.
Age
- 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.
Other
- Patients under judicial protection.
- No health insurance.
- Uncompensated hypothyroidism.
- Acute hyperthyroidism.
- Normal right ventricular volume.
- Participation in any other interventional clinical investigation that may have an impact on our study.
Who the study is looking for
- \>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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Not yet recruiting |
| Hôpital Cardiologique Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Hopital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Not yet recruiting |
| CHU Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Hôpital Michallon Coordinator of this site? Confirm its status | Grenoble | France | Not yet recruiting |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Hôpital Arnaud de Villeneuve Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Hôpital Laennec Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Groupe Hospitalo-Universitaire Carémeau Coordinator of this site? Confirm its status | Nîmes | France | Not yet recruiting |
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital De Haut Leveque Coordinator of this site? Confirm its status | Pessac | France | Not yet recruiting |
| Nouvel Hôpital Civil Coordinator of this site? Confirm its status | Strasbourg | France | Not yet recruiting |
| Hopital Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.