Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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.
Current treatment for ARVD is empirical and essentially based on treatment of arrhythmia. Thus, there is no validated treatment that will prevent the deterioration of the RV function in patients with ARVD.
The investigator's hypothesis is that the use of anti-fibrotic medications will prevent or at least reduce the deterioration of the RV function. The aim of this project is to evaluate the effect of spironolactone, a Potassium-sparing diuretic on ventricular myocardial remodeling and on arrhythmia burden in patients with ARVD.
The trial is a double-blind parallel multicenter prospective randomized phase II drug study. Patients will be randomized in the two groups: spironolactone or placebo. 13 centers in France will enroll the 120 patients (60 per group). Patients will be followed for 3 years (6 months, 1 year and 3 years) with all examinations (ECG, HA ECG, 24-hour Holter, trans-thoraciqc echocardiography (TTE), biological analyses) according to standard of care. A decrease in right and/or left ventricular deterioration and in arrhythmia burden are expected in ARVD patients treated with spironolactone. This reduction will improve the quality of life of patients and will reduce the number of hospitalizations and the risk of terminal heart failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Spironolactone
DrugThe doses used in the study are the doses used in standard clinical practice. Initial dose is 25 mg/day until study end . The duration of treatment for each patient is 12 months.
Placebo
DrugPlacebo will be taken once a day at the same time of day. The duration of treatment for each patient is 12 months.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Spironolactone groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Right ventricle longitudinal strain measured by echocardiography
Time frame
at year 12
Right ventricle infundibulum diameter measured by echocardiography
Time frame
at year 13
number of ventricular extrasystoles > 500 on 24h-Holter ECG
Time frame
at year 1Secondary outcomes
1
number of ventricular extrasystoles on 24h-Holter ECG
Time frame
at year 12
number of palpitations
Time frame
at year 13
number of palpitations
Time frame
at year 34
number of ventricular tachycardia
Time frame
at year 1Sponsors and contacts
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Source ClinicalTrials.gov