A randomised, double-blinded, placebo-controlled trial using cardiovascular magnetic resonance (CMR) scanning to assess remodelling and regression of fibrosis in cardiomyopathy with eplerenone

ISRCTN	ISRCTN23314770
DOI	https://doi.org/10.1186/ISRCTN23314770
Secondary identifying numbers	N0201163398

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Sanjay K Prasad
Scientific

Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom

Phone	+44 (0)20 7351 8194
Email	s.prasad@rbh.nthames.nhs.uk

Study design	Randomised double-blinded placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	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(s)	Riverside Research Ethics Committee Charing Cross Hospital (UK), 09/10/2006, ref 06/Q0401/50
Health condition(s) or problem(s) studied	Cardiovascular: Cardiomyopathy
Intervention	Eplerenone vs placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	27/10/2006
Completion date	26/10/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	140
Key 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.
Key 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
Date of first enrolment	27/10/2006
Date of final enrolment	26/10/2008

Royal Brompton & Harefield NHS Trust

London
SW3 6NP
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Royal Brompton and Harefield NHS Trust (UK), No External Funding, NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

12/10/2017: No publications found, verifying study status with principal investigator.