Antagonistas aldosterónicos en el tratamiento de pacientes con ventrículo derecho sistémico: ensayo clínico aleatorizado. - EVEDES STUDY.

Conditions: Transposición de grandes vasos tratada mediante la técnica de redirección auricular (técnicas de Senning o Mustard).
MedDRA version: 9.1Level: LLTClassification code 10010143Term: Complete transposition of great vessels
MedDRA version: 9.1Level: LLTClassification code 10044443Term: Transposition of the great vessels

Registration Number: EUCTR2007-002605-53-ES

Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i de Sant Pau

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Adult patients (>18 years).
Diagnosis of transposition of the great arteries corrected by means of atrial switch procedures (Senning or Mustard procedures).
Regular follow-up at a tertiary referral center.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Concomitant disease with life expectancy<1 year.
Inclusion in heart transplant waiting list.
Basal seric creatinine level>1.5mg/dl.
Basal seric potassium level>5.0mmol/L.
Intolerance to the investigational medical product.
Treatment with spironolactone or eplerenone within the previous 6 months.
Inability to undergo cardiac magnetic ressonance.
Pregnancy or breast feeding.
Denial of informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the impact of eplerenone in the reduction of right ventricular mass in adult patients with atrial switch procedures (Senning or Mustard) for transposition of the great arteries.;Secondary Objective: Right ventricular function.<br>Fibrous tissue mass.<br>Exercise capacity.;Primary end point(s): Myocardial mass index as assessed by cardiac magnetic ressonance.

Secondary Outcome Measures