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Could a common diuretic protect hearts in rare ARVD?

NCT ID NCT03593317

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether spironolactone, a potassium-sparing diuretic, can slow the deterioration of the right ventricle and reduce arrhythmias in people with arrhythmogenic right ventricular dysplasia (ARVD). About 120 participants will receive either spironolactone or a placebo for 12 months, with follow-up over 3 years. The goal is to see if this drug can improve quality of life and reduce hospitalizations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spironolactone
What this could lead to
If it works, this could point toward a treatment that slows heart muscle damage and reduces dangerous heart rhythms in people with ARVD.
What could go wrong
This is a phase 2 trial with only 120 participants, so results are preliminary. Spironolactone may not slow disease progression or reduce arrhythmias as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

arrhythmogenic right ventricular cardiomyopathy heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arrhythmogenic right ventricular dysplasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Amiens Picardie

    NOT_YET_RECRUITING

    Amiens, France

  • CHU Dijon

    RECRUITING

    Dijon, France

  • Groupe Hospitalo Universitaire Caremeau

    NOT_YET_RECRUITING

    Nîmes, France

  • Hôpital Arnaud de Villeneuve

    RECRUITING

    Montpellier, France

  • Hôpital Cardiologique Louis Pradel

    RECRUITING

    Bron, France

  • Hôpital Gabriel Montpied

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • Hôpital Laennec

    RECRUITING

    Nantes, France

  • Hôpital Michallon

    NOT_YET_RECRUITING

    Grenoble, France

  • Hôpital Pitié Salpetrière

    RECRUITING

    Paris, France

  • Hôpital Rangueil

    NOT_YET_RECRUITING

    Toulouse, France

  • Hôpital de Haut-Lévêque

    NOT_YET_RECRUITING

    Pessac, France

  • Hôpital de la Timone

    NOT_YET_RECRUITING

    Marseille, France

  • Nouvel Hôpital Civil

    NOT_YET_RECRUITING

    Strasbourg, France

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