Eplerenone in Systemic Right Ventricle

Phase 4

Completed

• Conditions: Transposition of Great Vessels; Atrial Switch Procedure
• Interventions: Drug: Eplerenone

• Registration Number: NCT00703352
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Study Start: 2008-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Eplerenone	Placebo
1	Eplerenone	Eplerenone

Primary Outcome Measures

Name	Time	Method
Right ventricular mass assessed by cardiac-magnetic resonance	1 year

Secondary Outcome Measures

Name	Time	Method
Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance	1 year

Trial Locations

Locations (1)

Hospital Universitari de la Vall d'Hebron; 🇪🇸 Barcelona, Spain