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BLOCKADE OF THE RENIN-ANGIOTENSIN-ALDOSTERONE SYSTEM IN PATIENTS WITH ARVD.BRAVE
EU CTIS ID: 2023-505048-20-00
What this study is testing
Evaluate the benefit of spironoclatone on the reduction of right ventricular deterioration and ventricular arrhythmia in patients with ARVD using echocardiography and 24h Holter-ECG.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient≥ 18 years
- 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
- LVEF >40%
- Signed written informed consent
- Patient on optimised medical treatment, including beta-blockers.
You likely can't join if
- Patients under judicial protection
- Normal right ventricular volume
- Heart transplantation
- Swallowing disorders
- Participation in any other interventional clinical investigation that may have an impact on our study
- 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.
See the full eligibility criteria
- Adult patient≥ 18 years
- 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
- LVEF >40%
- Signed written informed consent
- Patient on optimised medical treatment, including beta-blockers.
- Patients under judicial protection
- Normal right ventricular volume
- Heart transplantation
- Swallowing disorders
- Participation in any other interventional clinical investigation that may have an impact on our study
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.