CMR to Assess Fibrosis in Cardiomyopathy Using Eplerenone

• Status: Completed
• Trial end date: 2013-04-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Treatments: Eplerenone; Spironolactone

Criteria

Inclusion Criteria:

• Stable patients with an established diagnosis of cardiomyopathy as assessed by history, examination and typical ECG/Echo findings who are on maximally tolerated doses of appropriate drugs with no changes being made to the prescription in the 2 months preceding the start of the trial.

Exclusion Criteria:

• Patients already established on treatment with an aldosterone antagonist

• Patients with contraindications to eplerenone (hyperkalaemia, renal failure)

• Critically ill patients requiring respiratory and/or circulatory support

• Pacemaker or ICD

• Implanted ferromagnetic cerebrovascular clips

• Pregnant women (precautionary only)

• Intolerance of confined spaces

• Inability to lie supine for 60 minutes

• Unwilling or unable to give written informed consent

• Atrial fibrillation or ventricular bigemini.

• Any contraindication to CMR.

• Recent MI

• HCM patients who have received surgical/alcohol ablation treatment