Blocking a hormone system to treat heart issues in ARVD patients
Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD: a Double-blind Multicentre Prospective Randomized Study.
This study is testing if the medication spironolactone can help people with Arrhythmogenic Right Ventricular Dysplasia (ARVD) by slowing down heart problems and reducing irregular heartbeats.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 13 sites (Amiens and 12 other locations) |
| Trial ID | NCT03593317 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of spironolactone, an anti-fibrotic medication, on patients with Arrhythmogenic Right Ventricular Dysplasia (ARVD), a rare heart condition characterized by the replacement of heart muscle with fatty and fibrous tissue. The study is a double-blind, parallel, multicenter, randomized phase II trial where participants will receive either spironolactone or a placebo. The primary goal is to evaluate whether spironolactone can prevent or reduce the deterioration of right ventricular function and decrease the burden of arrhythmias in these patients. The trial will involve 13 centers and aims to provide a validated treatment approach for ARVD.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with ARVD based on established criteria and with a left ventricular ejection fraction greater than 40%.
Not a fit: Patients with right heart failure, severe renal or liver conditions, or contraindications to spironolactone will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with ARVD.
How similar studies have performed: While the approach of using anti-fibrotic medications is promising, this specific application in ARVD is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amiens and 12 other locations
- CHU Amiens Picardie — Amiens, France (Not_yet_recruiting)
- Hôpital Cardiologique Louis Pradel — Bron, France (Recruiting)
- Hôpital Gabriel Montpied — Clermont-Ferrand, France (Not_yet_recruiting)
- CHU Dijon — Dijon, France (Recruiting)
- Hôpital Michallon — Grenoble, France (Not_yet_recruiting)
- Hôpital de la Timone — Marseille, France (Not_yet_recruiting)
- Hôpital Arnaud de Villeneuve — Montpellier, France (Recruiting)
- Hôpital Laennec — Nantes, France (Recruiting)
- Groupe Hospitalo Universitaire Caremeau — Nîmes, France (Not_yet_recruiting)
- Hôpital Pitié Salpetrière — Paris, France (Recruiting)
- Hôpital de Haut-Lévêque — Pessac, France (Not_yet_recruiting)
- Nouvel Hôpital Civil — Strasbourg, France (Not_yet_recruiting)
- Hôpital Rangueil — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Philippe Chevalier, MD, PhD — Hospices Civils de Lyon
- Study coordinator: Roucher Aude, PhD
- Email: aude.roucher@chu-lyon.fr
- Phone: 426739447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.