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

Interventional


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

Condition

Transposition of Great Vessels

Intervention

Eplerenone

Study Arms / Comparison Groups

 1
Description:  Eplerenone

Publications

* 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

Drug

Estimated Enrollment

26

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Laura Dos, MD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT00703352

Organization ID

EudraCT: 2007-002605-53


Responsible Party

Sponsor

Study Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

 Pfizer

Study Sponsor

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


Verification Date

March 2017