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

Brief Title

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

Official Title

Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD: a Double-blind Multicentre Prospective Randomized Study.

Brief 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.

      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. 19 centers in
      France will enroll the 120 patients (60 per group). Patients will be followed up every 6
      months for 3 years. 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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Right ventricle volume measured by MRI

Secondary Outcome

 left ventricle measured by MRI

Condition

Arrhythmogenic Right Ventricular Dysplasia

Intervention

Spironolactone

Study Arms / Comparison Groups

 Spironolactone group
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

September 2021

Completion Date

September 2025

Primary Completion Date

September 2025

Eligibility Criteria

        Inclusion Criteria:

          -  >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.

          -  Increased right ventricular volume (> 100ml/m² female; > 110ml/m² male)

          -  Left Ventricular Ejection Fraction >40%

          -  Written informed consent.

        Exclusion Criteria:

          -  Pregnancy.

          -  No health insurance.

          -  MRI contraindication (claustrophobia, implantable defibrillator).

          -  Right heart failure patient (RV volume>150ml)

          -  Spironolactone contraindication (hypotension, renal failure).

          -  Normal right ventricular volume

          -  Heart transplantation

          -  Swallowing disorders
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Philippe Chevalier, MD, PhD, 4 72 35 73 81, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03593317

Organization ID

69HCL18_0038


Responsible Party

Sponsor

Study Sponsor

Hospices Civils de Lyon


Study Sponsor

Philippe Chevalier, MD, PhD, Principal Investigator, Hospices Civils de Lyon


Verification Date

March 2021