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NCT Number: NCT00703352

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 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.

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Key information

Conditions

Transposition of Great Vessels Atrial Switch Procedure Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari de la Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eplerenone

Drug

Eplerenone (coated tablet) 50mg daily during 12 months.

Primary outcomes

  1. Right ventricular mass assessed by cardiac-magnetic resonance

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: EVEDES

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2008
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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