drugset / Trial / NCT00401856

CMR to Assess Fibrosis in Cardiomyopathy Using Eplerenone

NCT00401856

Phase 4 Completed 42 enrolled Royal Brompton & Harefield NHS Foundation Trust
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this study is to determine if therapy with the aldosterone antagonist, Eplerenone, is associated with improved remodeling of the left ventricle in patients with cardiomyopathy. We will determine if any benefit to cardiac remodeling is associated with improved clinical outcomes, including improved exercise capacity and reduced incidence of major adverse cardiac events such as death, hospitalization for heart-failure, serious heart rhythm disturbances and transplantation. The null hypothesis is that therapy with Eplerenone over 12 months is associated with an improvement in cardiopulmonary exercise capacity and furthermore that treatment is associated with improved clinical outcomes. In order to test this hypothesis we will study stable patients on optimal drug therapy with documented cardiomyopathy using a trial design where therapy will be randomized, double-blinded and placebo-controlled. This will reduce the likelihood of any 'researcher bias'. Patients will be recruited from the Heart-failure Service at the Royal Brompton Hospital.

Timeline

Start
2007-12
Primary completion
2013-04-02
Completion
2013-04-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Eplerenone Unknown 50 mg Oral

Indications