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New treatment option for Arrhythmogenic Right Ventricular Dysplasia
Official title Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD
ClinicalTrials.gov ID: NCT03593317
What this study is testing
What is Spironolactone?
Spironolactone is an investigational medicine, being studied as a potential treatment for arrhythmogenic right ventricular dysplasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \>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...
- Left Ventricular Ejection Fraction \>40%
- Written informed consent.
You likely can't join if
- 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...
- 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...
- Mandatory indication for a combination of ACE inhibitor and sartan or renin inhibitor (each authorized separately).
See the full eligibility 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...
- 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...
- 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...
- 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 treatment clinical investigation that may have an impact on our study.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Bron, France
- Clermont-Ferrand, France
- Dijon, France
- Grenoble, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Nîmes, France
- Paris, France
- Pessac, France
- Strasbourg, France
- Toulouse, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Bron, France; Clermont-Ferrand, France; Dijon, France; Grenoble, France; Marseille, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.