Condition category
Circulatory System
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
14/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
+44 020 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 below to request a patient information sheet

Condition

Cardiovascular: Cardiomyopathy

Intervention

Eplerenone vs placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Eplerenone

Primary outcome measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes