| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN23314770 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0201163398 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cardiovascular: Cardiomyopathy |
| Study hypothesis | To demonstrate regression of fibrosis in patients with cardiomyopathy who are treated with eplerenone using cardiovascular magnetic resonance. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 27/10/2006 |
| Anticipated end date | 26/10/2008 |
| Status of trial | Ongoing |
| Target number of participants | 140 |
| Interventions | 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. |
| Primary outcome measure(s) | Reduction in amount of fibrosis as determined by CMR Late enhancement |
| Secondary outcome measure(s) | 1. Improvement in myocardial oxygen consumption (MVO2)
2. Reduction in major adverse cardiovascular events |
| Sources of funding | Royal Brompton and Harefield NHS Trust
No External Funding
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Sanjay K Prasad |
| Contact details | Royal Brompton & Harefield NHS Trust
Sydney Street
London
United Kingdom
SW3 6NP |
| Contact telephone | +44 020 7351 8194 |
| Contact fax | +44 |
| Contact email | s.prasad@rbh.nthames.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN23314770 |
| Date last extracted from ISRCTN register | 17/04/2008 |
