Arrhythmogenic Right Ventricular DysplasiaPhase 2BRAVENCT03593317
Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD
A Phase 2 study testing Spironolactone in people with Arrhythmogenic Right Ventricular Dysplasia, run by Hospices Civils de Lyon at 13 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmogenic Right Ventricular Dysplasia
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 13 sitesFrance
- Study dates
- 20 Dec 2024to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Not yet recruiting
CHU Amiens Picardie
Amiens
Maciej KUBALA, Dr, +33 322 087 230, kubala.maciej@chu-amiens.fr
Maciej KUBALA, Dr
- Recruiting
Hôpital Cardiologique Louis Pradel
Bron
Philippe Chevalier, Pr, +33 472 357 027, philippe.chevalier@chu-lyon.fr
- Not yet recruiting
Hôpital Gabriel Montpied
Clermont-Ferrand
Gregoire MASSOULIE, Dr, +33 473 751 410, gmassoulie@chu-clermontferrand.fr
Gregoire MASSOULIE, Dr
- Recruiting
CHU Dijon
Dijon
Gabriel Laurent, Dr, +33 380 293 536, gabriel.laurent@chu-dijon.fr
Gabriel Laurent, Dr
- Not yet recruiting
Hôpital Michallon
Grenoble
Pascal DEFAYE, Pr, +33 476 765 507, pdefaye@chu-grenoble.fr
Pascal DEFAYE, Pr
- Not yet recruiting
Hôpital de la Timone
Marseille
Jerome HOURDAIN, Dr, +33 491 386 575, Jerome.HOURDAIN@ap-hm.fr
Jerome HOURDAIN, Dr
- Recruiting
Hôpital Arnaud de Villeneuve
Montpellier
François ROUBILLE, Dr, +33 467 336 187, f-roubille@chu-montpellier.fr
François ROUBILLE, Dr
- Recruiting
Hôpital Laennec
Nantes
Vincent PROBST, Pr, +33 240165008, vincent.probst@chu-nantes.fr
Vincent PROBST, Pr
- Not yet recruiting
Groupe Hospitalo Universitaire Caremeau
Nîmes
Pierre-François WINUM, Dr, +33 466 683 116, pierre.winum@chu-nimes.fr
Pierre-François WINUM, Dr
- Recruiting
Hôpital Pitié Salpetrière
Paris
Estelle GANDJBAKHCH, Dr, estelle.gandjbakhch@aphp.fr
Estelle GANDJBAKHCH
- Not yet recruiting
Hôpital de Haut-Lévêque
Pessac
Frédéric SACHER, Dr, +33 556 795 679, frederic.sacher@chu-bordeaux.fr
Frédéric SACHER, Dr
- Not yet recruiting
Nouvel Hôpital Civil
Strasbourg
Laurence JESEL-MOREL, Pr, +33 369 550 636, laurence.jesel@chru-strasbourg.fr
Laurence JESEL-MOREL, Pr
- Not yet recruiting
Hôpital Rangueil
Toulouse
Philippe MAURY, Pr, +33 561 323 470, maury.p@chu-toulouse.fr
Philippe MAURY, Pr
About this study
Official title: Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD: a Double-blind Multicentre Prospective Randomized Study.
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.
Read more
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.
- Being tested
- Spironolactone, Placebo
- Keywords
- Heart Failure, Right ventricle
- Medical subject headings
- Arrhythmogenic Right Ventricular Dysplasia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
The 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.
PlaceboDrug
Placebo will be taken once a day at the same time of day. The duration of treatment for each patient is 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone group | Experimental | Not described Receives: Drug: Spironolactone |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricle longitudinal strain measured by echocardiography
Measured: at year 1
Right ventricle infundibulum diameter measured by echocardiography
Measured: at year 1
number of ventricular extrasystoles > 500 on 24h-Holter ECG
Measured: at year 1
Secondary outcomes (48)
number of ventricular extrasystoles on 24h-Holter ECG
Measured: at year 1
number of palpitations
Measured: at year 1
number of palpitations
Measured: at year 3
number of ventricular tachycardia
Measured: at year 1
number of ventricular tachycardia
Measured: at year 3
number of dyspnea
Measured: at year 1
number of dyspnea
Measured: at year 3
number of syncope
Measured: at year 1
number of syncope
Measured: at year 3
number of sudden death
Measured: at year 1
number of sudden death
Measured: at year 3
number of thoracic pain
Measured: at year 1
number of thoracic pain
Measured: at year 3
number of MACE (Major adverse cardiac events)
Measured: at year 1
number of MACE (Major adverse cardiac events)
Measured: at year 3
number of hospital admissions
Measured: at year 1
number of hospital admissions
Measured: at year 3
left ventricle diameters measured by echocardiography
Morphologic criterion
Measured: at year 1
left ventricle diameters measured by echocardiography
Morphologic criterion
Measured: at year 3
left ventricle volumes measured by echocardiography
Morphologic criterion
Measured: at year 1
left ventricle volumes measured by echocardiography
Morphologic criterion
Measured: at year 3
left ventricle ejection fraction measured by echocardiography
Morphologic criterion
Measured: at year 1
left ventricle ejection fraction measured by echocardiography
Morphologic criterion
Measured: at year 3
Left ventricular global longitudinal strain measured by echocardiography
Morphologic criterion
Measured: at year 1
aneurism measured by echocardiography
Morphologic criterion
Measured: at year 1
aneurism measured by echocardiography
Morphologic criterion
Measured: at year 3
dyskinesia measured by echocardiography
Morphologic criterion
Measured: at year 1
dyskinesia measured by echocardiography
Morphologic criterion
Measured: at year 3
evolution of QRS width (50mm/s) on ECG
Morphologic criterion
Measured: at year 1
number of ventricular extrasystoles on 24h Holter ECG
Rhythmic criterion
Measured: at year 1
sustained ventricular tachycardia on 24h Holter ECG
Rhythmic criterion
Measured: at year 1
evolution of PR interval duration on ECG
Rhythmic criterion
Measured: at year 1
late potentials measured with high amplification ECG
Rhythmic criterion
Measured: at year 3
number of ventricular extrasystoles by stress test
Rhythmic criterion
Measured: at year 3
Evolution of functional symptoms by recording adverse events
Functional criteria
Measured: at year 3
Number of hospital admissions owing to clinical deterioration
Measured: at year 3
Evolution of telediastolic right ventricle volume measured by echocardiography
according to the genotype of desmosome genes
Measured: at year 3
arrhythmia burden measured by 24h Holter ECG
according to the genotype of desmosome genes
Measured: at year 3
Dosage of MMP9 (Matrix metallopeptidase 9)
Quantification of fibrosis
Measured: at year 1
Dosage of MMP9 (Matrix metallopeptidase 9)
Quantification of fibrosis
Measured: at year 3
Dosage of TIMP1 (Tissue Inhibitory MetalloProtease 1)
Quantification of fibrosis
Measured: at year 1
Dosage of TIMP1 (Tissue Inhibitory MetalloProtease 1)
Quantification of fibrosis
Measured: at year 3
Dosage of TIMP2 (Tissue Inhibitory MetalloProtease 2)
Quantification of fibrosis
Measured: at year 1
Dosage of TIMP2 (Tissue Inhibitory MetalloProtease 2)
Quantification of fibrosis
Measured: at year 3
Dosage of IL6 (Interleukin 6)
Quantification of inflammation
Measured: at year 1
Dosage of IL6 (Interleukin 6)
Quantification of inflammation
Measured: at year 3
Dosage of IL8 (Interleukin 8)
Quantification of inflammation
Measured: at year 1
Dosage of IL8 (Interleukin 8)
Quantification of inflammation
Measured: at year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start20 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arrhythmogenic Right Ventricular DysplasiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Chevalier, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593317
- Sponsor's protocol ID
- 69HCL18_0038
- Other IDs
- 2023-505048-20-00, 2023
- Acronym
- BRAVE
- Status last verified
- Feb 2026
- First submitted
- 10 Jul 2018
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alexandrino FB, Faaborg-Andersen CC, daSilva-deAbreu A. Anticoagulation in patients with atrial fibrillation and heart failure: More than meets the eye? Int J Cardiol. 2024 Feb 15;397:131591. doi: 10.1016/j.ijcard.2023.131591. Epub 2023 Nov 17. No abstract available.
PubMed 37979797
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD: a Double-blind Multicentre Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT03593317
- Acronym / sponsor ID
- BRAVE / 69HCL18_0038
- Keywords
- Heart Failure, Right ventricle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone group | Experimental | Drug: Spironolactone |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpironolactoneThe 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. | Drug | Spironolactone group |
| PlaceboPlacebo will be taken once a day at the same time of day. The duration of treatment for each patient is 12 months. | Drug | Placebo group |
Primary outcome
Right ventricle longitudinal strain measured by echocardiography
Time frame: at year 1
Right ventricle infundibulum diameter measured by echocardiography
Time frame: at year 1
number of ventricular extrasystoles > 500 on 24h-Holter ECG
Time frame: at year 1
48 secondary outcomes
number of ventricular extrasystoles on 24h-Holter ECG
Time frame: at year 1
number of palpitations
Time frame: at year 1
number of palpitations
Time frame: at year 3
number of ventricular tachycardia
Time frame: at year 1
number of ventricular tachycardia
Time frame: at year 3
number of dyspnea
Time frame: at year 1
number of dyspnea
Time frame: at year 3
number of syncope
Time frame: at year 1
number of syncope
Time frame: at year 3
number of sudden death
Time frame: at year 1
number of sudden death
Time frame: at year 3
number of thoracic pain
Time frame: at year 1
number of thoracic pain
Time frame: at year 3
number of MACE (Major adverse cardiac events)
Time frame: at year 1
number of MACE (Major adverse cardiac events)
Time frame: at year 3
number of hospital admissions
Time frame: at year 1
number of hospital admissions
Time frame: at year 3
left ventricle diameters measured by echocardiography
Time frame: at year 1
left ventricle diameters measured by echocardiography
Time frame: at year 3
left ventricle volumes measured by echocardiography
Time frame: at year 1
left ventricle volumes measured by echocardiography
Time frame: at year 3
left ventricle ejection fraction measured by echocardiography
Time frame: at year 1
left ventricle ejection fraction measured by echocardiography
Time frame: at year 3
Left ventricular global longitudinal strain measured by echocardiography
Time frame: at year 1
aneurism measured by echocardiography
Time frame: at year 1
aneurism measured by echocardiography
Time frame: at year 3
dyskinesia measured by echocardiography
Time frame: at year 1
dyskinesia measured by echocardiography
Time frame: at year 3
evolution of QRS width (50mm/s) on ECG
Time frame: at year 1
number of ventricular extrasystoles on 24h Holter ECG
Time frame: at year 1
sustained ventricular tachycardia on 24h Holter ECG
Time frame: at year 1
evolution of PR interval duration on ECG
Time frame: at year 1
late potentials measured with high amplification ECG
Time frame: at year 3
number of ventricular extrasystoles by stress test
Time frame: at year 3
Evolution of functional symptoms by recording adverse events
Time frame: at year 3
Number of hospital admissions owing to clinical deterioration
Time frame: at year 3
Evolution of telediastolic right ventricle volume measured by echocardiography
Time frame: at year 3
arrhythmia burden measured by 24h Holter ECG
Time frame: at year 3
Dosage of MMP9 (Matrix metallopeptidase 9)
Time frame: at year 1
Dosage of MMP9 (Matrix metallopeptidase 9)
Time frame: at year 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 37979797Alexandrino FB, Faaborg-Andersen CC, daSilva-deAbreu A. Anticoagulation in patients with atrial fibrillation and heart failure: More than meets the eye? Int J Cardiol. 2024 Feb 15;397:131591. doi: 10.1016/j.ijcard.2023.131591. Epub 2023 Nov 17. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Chevalier, MD, PhD principal investigator
Hospices Civils de Lyon
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolactone in people with Arrhythmogenic Right Ventricular Dysplasia, run by Hospices Civils de Lyon at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roucher Aude, PhD (426739447 ext. +33, aude.roucher@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricle longitudinal strain measured by echocardiography (time frame: at year 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03593317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.