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
Conditions
Interventions
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
Ph
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i de Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Concomitant disease with life expectancy1.5mg/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Fibrous tissue mass. Exercise capacity.;Primary end point(s): Myocardial mass index as assessed by cardiac magnetic ressonance. | — |
Countries
Spain
Outcome results
None listed