Eplerenone in Systemic Right Ventricle

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Brief Title

Eplerenone in Systemic Right Ventricle

Official Title

Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial.

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 resonance studies have shown a significant degree of myocardial
      fibrosis in right ventricles in the systemic position, which predisposes to systolic and
      diastolic dysfunction. Aldosterone is a widely recognized neurohormonal marker involved in
      the formation of myocardial fibrosis and the treatment with aldosterone antagonists has shown
      a decrease in ventricular mass in hypertensive patients, presumably related to reduction of
      myocardial fibrosis.

      HYPOTHESIS: Low dose of eplerenone, a selective mineralocorticoid receptor blocker, in
      patients with systemic right ventricle can reduce the ventricular mass by means of a
      reduction in myocardial fibrosis, resulting in improved systolic function.

      PATIENTS AND METHODS: Randomized, double blind, parallel clinical trial comparing eplerenone
      (50mg daily) with placebo.

      Study population: Adult patients (>18 years) diagnosed with repaired transposition of the
      great arteries with atrial switch (Senning or Mustard techniques) routinely followed at a
      tertiary referral center.

      Duration: 12 months. Outcomes: Right ventricular mass, myocardial fibrosis mass and ejection
      fraction assessed by cardiac magnetic resonance.

Study Phase

Phase 4

Study Type


Primary Outcome

Right ventricular mass assessed by cardiac-magnetic resonance

Secondary Outcome

 Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance


Transposition of Great Vessels



Study Arms / Comparison Groups

Description:  Eplerenone


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

July 2008

Completion Date

December 2010

Primary Completion Date

December 2010

Eligibility Criteria

        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.




18 Years - N/A

Accepts Healthy Volunteers



Laura Dos, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID

EudraCT: 2007-002605-53

Responsible Party


Study Sponsor

Hospital Universitari Vall d'Hebron Research Institute



Study Sponsor

Laura Dos, MD, Principal Investigator, Hospital Vall d'Hebron

Verification Date

March 2017