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

INTERVENTION: Trade Name: Inspra Pharmaceutical Form: Coated tablet INN or Proposed INN: EPLERENONE CAS Number: 107724209 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 25‐50 Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use CONDITION: Transposición de grandes vasos tratada mediante la técnica de redirección auricular (técnicas de Senning o Mustard). ; MedDRA version: 9.1 Level: LLT Classification code 10010143 Term: Complete transposition of great vessels ; MedDRA version: 9.1 Level: LLT Classification code 10044443 Term: Transposition of the great vessels PRIMARY OUTCOME: 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. Primary end point(s): Myocardial mass index as assessed by cardiac magnetic ressonance. Secondary Objective: Right ventricular function.; Fibrous tissue mass.; Exercise capacity. 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