Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03593317 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD

Study acronym: BRAVE
StatusRecruiting
PhasePhase 2
Started2024-12-20
View on ClinicalTrials.gov ↗

Amendment history

2026-02-05
Study Status, Oversight, Eligibility, Contacts/Locations v12
Eligibility criteria+8 characters
[...] patient (RV volume>150ml). Spironolactone contraindication: anuria, hyperkalemia (K+>5 mmol/l), renal failure (DFGCréat>22 mL/m [...]
Study sitesdetails revised at 4 of 13 sites
2025-02-21
Study Status, Oversight, Eligibility v11
Eligibility criteria-72 characters
[...] diology/International Society and Federation of Cardiology. Increased right ventricular volume (> 100ml/m² female; > 110ml/m² male) Left Ventricular Ejection Fraction >40% Written informed con [...]
2025-01-15
Study Status v10
Start dateestimated 2024-12→confirmed 2024-12-20
2024-12-02
Study Status v9
Primary completion date2027-11→2027-12
Completion date2029-11→2029-12
Start date2024-11→2024-12
2024-11-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-03→2027-11
Completion date2028-03→2029-11
Start date2024-03→2024-11
Study sites1→13
Show 7 earlier versions
2023-12-26
Study Status v7
Primary completion date2027-11→2028-03
Completion date2027-11→2028-03
Start date2023-11→2024-03
2023-08-03
Study Identification, Study Status, Contacts/Locations v6
Primary completion date2027-09→2027-11
Completion date2027-09→2027-11
Start date2023-09→2023-11
2023-05-15
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v5
Primary completion date2026-09→2027-09
Completion date2026-09→2027-09
Start date2022-09→2023-09
Eligibility criteria+1,079 characters
[...] Fraction >40% Written informed consent. Exclusion Criteria: PregnancyPatients 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 bir [...] No health insurance. MRI contraindication (claustrophobia, implantable defibrillator). Right heart failure patient (RV volume>150ml). Spironolactone contraindication: hyperkalemia (hypotensionK+> [...] [...]
Secondary endpoints21 to 48 entries
number of ventricular extrasystoles on 24h-Holter ECG number of palpitations number of palpitations number of ventricular tachycardia number of ventricular tachycardia number of dyspnea number of dyspnea number of syncope number of syncope number of sudden death number of sudden death number of thor [...] left ventricle diameters measured by MRIechocardiography left ventricle diameters measured by echocardiography left ventricle volumes measured by echocardiography left ventricle volumes measured by echocardiography left ventricle ejection fraction measured by echocardiography left ventricle ejection [...] [...]
Primary endpoints2 to 3 entries
Right ventricle volumeinfundibulum diameter measured by MRIechocardiography Right ventricle longitudinal strain measured by echocardiography number of ventricular extrasystoles > 500 on 24h-Holter ECG
2022-07-05
Study Status v4
Primary completion date2025-09→2026-09
Completion date2025-09→2026-09
Start date2021-09→2022-09
2021-03-19
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v3
PhasePhase 3→Phase 2
Primary completion date2025-01→2025-09
Completion date2025-01→2025-09
Start date2021-01→2021-09
InterventionsPlacebo (Drug), Ramipril (Drug)→Placebo (Drug), Spironolactone (Drug)
Eligibility criteria+6 characters
[...] fibrillator). Right heart failure patient (RV volume>150ml) RamiprilSpironolactone contraindication (hypotension, renal failure). Normal right [...]
2019-12-18
Study Status v2
Primary completion date2023-01→2025-01
Completion date2023-01→2025-01
Start date2019-01→2021-01
2018-07-19
Study Identification, Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+30 characters
[...] ght ventricular volume (> 100ml/m² female; > 110ml/m² male) LVEFLeft Ventricular Ejection Fraction >40% Written informed consent. Exclusion Criteria: Pregnanc [...]
Secondary endpoints21 entries, revised
aneuvrismaneurism measured by MRI aneuvrismaneurism measured by echocardiography evolution of PR interval duration on ECG Dosage of MMP9 (Matrix metallopeptidase 9) Dosage of TIMP1 (Tissue Inhibitory MetalloProtease 1) Dosage of TIMP2 (Tissue Inhibitory MetalloProtease 2) Dosage of IL6 (Interleukin 6) Dosage of IL8 (Interleukin 8)
Study title+1 characters
Blockade of the Renin-angiotensin-aldosterone YstemSystem in Patients With ARVD
2018-07-19
Original filing
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.
Trial Details
NCT Number NCT03593317
Lead Sponsor Hospices Civils de Lyon
Conditions Arrhythmogenic Right Ventricular Dysplasia
Enrollment 120 participants
Start Date 2024-12-20
Primary Completion 2027-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-09