Contact information
Type
Scientific
Primary contact
Dr Sanjay K Prasad
ORCID ID
Contact details
Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7351 8194
s.prasad@rbh.nthames.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0201163398
Study information
Scientific title
A randomised, double-blinded, placebo-controlled trial using cardiovascular magnetic resonance (CMR) scanning to assess remodelling and regression of fibrosis in cardiomyopathy with eplerenone
Acronym
Study hypothesis
To demonstrate regression of fibrosis in patients with cardiomyopathy who are treated with eplerenone using cardiovascular magnetic resonance. This trial compares patients taking the drug eplerenone with patients who don't and whether it reduces the amount of fibrosis (scarring) of the heart.
Ethics approval
Riverside Research Ethics Committee Charing Cross Hospital (UK), 09/10/2006, ref 06/Q0401/50
Study design
Randomised double-blinded placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cardiovascular: Cardiomyopathy
Intervention
Eplerenone vs placebo
Intervention type
Drug
Phase
Not Applicable
Drug names
Eplerenone
Primary outcome measure
Reduction in amount of fibrosis as determined by CMR Late enhancement
Secondary outcome measures
1. Improvement in myocardial oxygen consumption (MVO2)
2. Reduction in major adverse cardiovascular events
Overall trial start date
27/10/2006
Overall trial end date
26/10/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Patients already established on treatment with an aldosterone antagonist
2. Patients with contraindications to eplerenone (hyperkalaemia, renal failure)
3. Critically ill patients requiring respiratory and/or circulatory support
4. Pacemaker or ICD
5. Implanted ferromagnetic cerebrovascular clips
6. Pregnant women (precautionary only)
7. Intolerance of confined spaces
8. Inability to lie supine for 60 minutes
9. Unwilling or unable to give written informed consent
10.Atrial fibrillation or ventricular bigeminy
11. Any contraindication to CMR.
12. Recent MI
13. HCM patients who have received surgical/alcohol ablation treatment
Recruitment start date
27/10/2006
Recruitment end date
26/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Brompton & Harefield NHS Trust
London
SW3 6NP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Brompton and Harefield NHS Trust (UK), No External Funding, NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list