Blocking a hormone system to treat heart issues in ARVD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital Cardiologique Louis Pradel
  Bron, France Recruiting
• CHU Dijon
  Dijon, France Recruiting
• Hôpital Arnaud de Villeneuve
  Montpellier, France Recruiting
• Hôpital Laennec
  Nantes, France Recruiting
• Hôpital Pitié Salpetrière
  Paris, France Recruiting
• CHU Amiens Picardie
  Amiens, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.