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ISRCTN
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ISRCTN23314770
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ClinicalTrials.gov identifier
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Public title
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A Randomised, Double-blinded, Placebo-controlled Trial Using Cardiovascular Magnetic Resonance (CMR) Scanning to Assess Remodelling and Regression of Fibrosis in Cardiomyopathy with Eplerenone
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0201163398
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Study hypothesis
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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.
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Ethics approval
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Added 27 August 2008: Riverside Research Ethics Committee Charing Cross Hospital (UK), 09/10/06, ref 06/Q0401/50.
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Study design
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Randomised double-blinded placebo-controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular: Cardiomyopathy
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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27/10/2006
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Anticipated end date
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26/10/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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140
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Interventions
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Eplerenone vs placebo
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Primary outcome measure(s)
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Reduction in amount of fibrosis as determined by CMR Late enhancement
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Secondary outcome measure(s)
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1. Improvement in myocardial oxygen consumption (MVO2)
2. Reduction in major adverse cardiovascular events
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Sources of funding
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Royal Brompton and Harefield NHS Trust (UK), No External Funding, NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
Sanjay K
Prasad
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Address
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Royal Brompton & Harefield NHS Trust
Sydney Street
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City/town
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London
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Zip/Postcode
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SW3 6NP
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Country
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United Kingdom
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Tel
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+44 020 7351 8194
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Fax
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+44
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Email
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s.prasad@rbh.nthames.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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27/08/2008
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Date ISRCTN assigned
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28/09/2007
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