Clinical Trials Directory

Trials / Completed

CompletedNCT00703352

Eplerenone in Systemic Right Ventricle

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGEplerenoneEplerenone (coated tablet) 50mg daily during 12 months.

Timeline

Start date
2008-07-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2008-06-23
Last updated
2017-03-22

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT00703352. Inclusion in this directory is not an endorsement.