Status:
COMPLETED
Eplerenone in Systemic Right Ventricle
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Pfizer
Conditions:
Transposition of Great Vessels
Atrial Switch Procedure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
BACKGROUND: There is no clinical evidence supporting medical treatment for the failing systemic right ventricle in patients with transposition of the great vessels with atrial switch. Cardiac magnetic...
Eligibility Criteria
Inclusion
- Adult patients (\>18 years old)
- Diagnosis of transposition of the great arteries repaired with atrial switch procedures (Mustard or Senning).
- Regular follow up at tertiary referral center.
Exclusion
- Concomitant disease with life expectancy \<1 year.
- Inclusion in heart transplant waiting list.
- Basal serum creatinine level \> 1.5 mg/dl.
- Basal serum potassium level \> 5.0 mmol/L.
- Intolerance to the investigational medical product.
- Treatment with spironolactone or eplerenone within the previous 6 months.
- Inability to undergo magnetic resonance imaging.
- Pregnancy or breast feeding.
- Denial of informed consent.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00703352
Start Date
July 1 2008
End Date
December 1 2010
Last Update
March 22 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitari de la Vall d'Hebron
Barcelona, Barcelona, Spain, 08035