Stratified medicine of eplerenone in acute MI/injury
Research type
Research Study
Full title
The effect of mineralocorticoid receptor antagonist therapy in patients with acute myocardial infarction or injury and cardiovascular risk factors: a registry-based, stratified-medicine, randomised, controlled trial
IRAS ID
283466
Contact name
Colin Berry
Contact email
Sponsor organisation
Golden Jubilee National Hospital / National Waiting Times Board
Clinicaltrials.gov Identifier
Duration of Study in the UK
19 years, 11 months, 31 days
Research summary
Patients with heart attack or heart injury are tested (angiogram) for blockages in their arteries. Many patients develop heart problems caused by damage to small, “microvascular” blood vessels. These issues are also relevant to patients with COVID-19. Eplerenone reduces blood vessel injury and is used to treat heart failure.
AIM: to test the use of eplerenone in patients with heart attack/heart injury who have small vessel disease, including patients with COVID-19
We will recruit patients referred to the Golden Jubilee hospital with a suspected heart attack heart / injury into a registry. Screening, enrolment and verbal, informed consent will be obtained during the angiogram then written consent on the ward. Small vessel disease will be assessed using a ‘diagnostic’ guidewire during the standard angiogram. We will allocate people with small vessel problems to a trial of usual care or eplerenone.
Patients will be allocated into one of the 3 groups:
-Group 1: Patients with normal small vessel function. No eplerenone
-Group 2: Small vessels abnormal. Usual care, no eplerenone.
-Group 3: Small vessels abnormal. Eplerenone tablets.The primary outcome for the trial will be reduced heart injury (biomarkers) in patients with microvascular disease. We will also test heart function (MRI scan) and physical functioning (a short walking test) at 1 month and 6 months. All patients (Groups 1, 2 and 3) will have an angiogram and standard blood tests during the hospital stay, and then again at 1 and 6 months. Other outcomes include questionnaires (health status). We will gather information on longer-term health outcomes (hospitalisation, death) using confidential electronic record linkage. We will ask for permission to store blood samples for future research.
The research will improve our understanding of eplerenone therapy in this patient group. Our study will create a biorepository of clinical samples and images which will provide vital data for studies of COVID-19.
REC name
West of Scotland REC 5
REC reference
20/WS/0075
Date of REC Opinion
26 May 2020
REC opinion
Favourable Opinion