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COMPLETEDPhase 4NCT00703352

Eplerenone in Systemic Right Ventricle

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...

Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Pfizer

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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 Criteria

•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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 22, 2017Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment26

Start dateJul 2008

Last updatedMar 22, 2017

Condition

Transposition of Great Vessels Atrial Switch Procedure

Locations shown

Hospital Universitari de la Vall d'Hebron

Barcelona, Barcelona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2017Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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