Blockade of the renin-angiotensin-aldosterone system in patients with arrhythmogenic right ventricular dysplasia: A
Elodie Morel1, Ab Waheed Manati2, Patrice Nony3
1Service Rythmologie, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Lyon, France.
Insights
The BRAVE study investigates ramipril for arrhythmogenic right ventricular dysplasia (ARVD), aiming to reduce right ventricular deterioration and arrhythmia. This research seeks a treatment to prevent disease progression and improve patient quality of life.
Area of Science:
- Cardiology
- Pharmacology
- Medical Research
Background:
- Arrhythmogenic right ventricular dysplasia (ARVD) is a rare cardiomyopathy causing fatty and fibrous tissue replacement in the right ventricle.
- Current ARVD treatments are empirical, focusing on arrhythmia management rather than disease modification.
- No antifibrotic therapies have been validated for ARVD, highlighting a critical unmet need.
Purpose of the Study:
- To evaluate the efficacy of ramipril, an ACE inhibitor, in mitigating ventricular myocardial remodeling and arrhythmia burden in ARVD patients.
- To assess ramipril's potential to prevent the deterioration of right ventricular function in ARVD.
- To explore the antifibrotic effects of ramipril in the context of ARVD.
Main Methods:
- The BRAVE study is a phase 4, double-blind, randomized, multicenter trial.
- 120 ARVD patients will be randomized to receive either ramipril or a placebo for 3 years.
- Co-primary endpoints include changes in telediastolic right ventricular volume (via MRI) and arrhythmia burden over 3 years.
Main Results:
- This section is to be filled after the study's completion.
- Expected outcomes include reduced right and/or left ventricular deterioration and a decreased arrhythmia burden in the ramipril group.
- Anticipated benefits encompass improved quality of life and reduced hospitalizations for ARVD patients.
Conclusions:
- The BRAVE study aims to establish ramipril as a disease-modifying therapy for ARVD.
- Positive results could lead to a novel treatment strategy for ARVD, addressing the current lack of disease-specific interventions.
- This research may significantly improve long-term outcomes for patients suffering from this debilitating cardiomyopathy.
Abstract:
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 RV function in patients with ARVD. The aim of the BRAVE study is to evaluate the effect of ramipril, an angiotensin-converting enzyme inhibitor, on ventricular myocardial remodeling and arrhythmia burden in patients with ARVD. Despite the fact that myocardial fibrosis is one of the structural hallmarks of ARVD, no study has tested an antifibrotic drug in ARVD patients. The trial is a double-blind, parallel, multicenter, prospective, randomized, phase 4 drug study. Patients will be randomized into 2 groups, ramipril or placebo. The 120 patients (60 per group) will be enrolled by 26 centers in France. Patients will be followed up every 6 months for 3 years. The 2 co-primary endpoints are defined as the difference of telediastolic RV volume measured by magnetic resonance imaging between baseline and 3 years of follow-up, and the change in arrhythmia burden during the 3 years of follow-up. A decrease in RV and/or left ventricular deterioration and in arrhythmia burden are expected in ARVD patients treated with ramipril. This reduction will improve quality of life of patients and will reduce the number of hospitalizations and the risk of terminal heart failure.
More Related Videos
Related Concept Videos
Heart Failure Drugs: Inhibitors of Renin-Angiotensin System
Blind Procedures
Hormonal Regulation
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
Bioavailability Study Design: Healthy Subjects Versus Patients
Neuromuscular Junction And Blockade


