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Eplerenone in Systemic Right Ventricle (EVEDES)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00703352
First received: June 20, 2008
Last updated: November 30, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Transposition of the Great Vessels With Atrial Switch.
 Drug: Eplerenone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial.

Resource links provided by NLM:

Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Right ventricular mass assessed by cardiac-magnetic resonance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Enrollment: 26
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Eplerenone
 Drug: Eplerenone
Eplerenone (coated tablet) 50mg daily during 12 months.
Placebo Comparator: 2
Placebo
 Drug: Eplerenone
Eplerenone (coated tablet) 50mg daily during 12 months.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703352

Locations
Spain
Hospital Universitari de la Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Pfizer
Investigators
Principal Investigator: Laura Dos, MD Hospital Vall d'Hebron
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT00703352     History of Changes
Other Study ID Numbers: EudraCT: 2007-002605-53 
Study First Received: June 20, 2008
Last Updated: November 30, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Transposition of the great arteries.
Transposition of the great vessels.
Mustard.
Senning.

Additional relevant MeSH terms:
Transposition of Great Vessels
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Eplerenone
Spironolactone
 Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on September 30, 2016