Eplerenone in Systemic Right Ventricle

Transposition of Great Vessels Clinical Trial

— EVEDES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703352
• Other study ID #: EudraCT: 2007-002605-53
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2008
• Last updated: March 21, 2017
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Switch Procedure
• Transposition of Great Vessels

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari de la Vall d'Hebron	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular mass assessed by cardiac-magnetic resonance		1 year
Secondary	Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance		1 year