EUCTR2007-002605-53-ES
Active, not recruiting
Not Applicable
Antagonistas aldosterónicos en el tratamiento de pacientes con ventrículo derecho sistémico: ensayo clínico aleatorizado. - EVEDES STUDY.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i de Sant Pau0 sitesApril 11, 2008
ConditionsTransposición 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 vesselsMedDRA version: 9.1Level: LLTClassification code 10044443Term: Transposition of the great vessels
DrugsInspra
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transposición de grandes vasos tratada mediante la técnica de redirección auricular (técnicas de Senning o Mustard).
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i de Sant Pau
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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