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CMR to Assess Fibrosis in Cardiomyopathy Using Eplerenone

NCT00401856 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-09-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Eplerenone

50mg oral route

DRUG

Placebo

Placebo is identical to eplerenone but the active ingredient is absent

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Sanjay Prasad, MD, MRCP · Royal Brompton & Harefield NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2013-04-02
Completion
2013-04-02

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00401856 on ClinicalTrials.gov