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Clinical Trials/EUCTR2007-002605-53-ES
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

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.

Registry
who.int
Start Date
April 11, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

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

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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