Status:
COMPLETED
CMR to Assess Fibrosis in Cardiomyopathy Using Eplerenone
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Cardiomyopathy
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief 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 dete...
Detailed Description
Our aim is to recruit 140 patients (based on statistical power calculation in). These patients will be recruited from the cardiology clinics at The Royal Brompton Hospital as well as from a database o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00401856
Start Date
December 1 2007
End Date
April 2 2013
Last Update
September 21 2021
Active Locations (1)
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1
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP