Stratified Medicine of Eplerenone in Acute MI/Injury (StratMed-MINOCA)

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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

Patients referred to the Golden Jubilee hospital with a suspected heart attack heart / injury will be invited to participate into a registry-based clinical trial. 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. People with small vessel problems will be allocated to a clinical 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) at enrolment and at six months. All patients (Groups 1, 2 and 3) will have an angiogram. Standard blood tests will be collected 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 scientific knowlege about eplerenone therapy in this patient group. The study will create a repository of clinical samples and images which will provide vital data for studies of COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS National Waiting Times Centre Board
• Collaborators: Abbott; British Heart Foundation
• Treatments: Eplerenone

Criteria

Inclusion Criteria:

• Age ≥18 years.

• Acute myocardial infarction or myocardial injury and no obstructive coronary arteries.

• Cardiovascular risk factor (≥1): age >70 years, atrial fibrillation, diabetes, current smoker, eGFR 30 - 60 mL/ minute/1.73 m2, prior MI, treated hypertension or COVID-19 (confirmed or suspected)

• Coronary angiography.

Exclusion Criteria (trial):

• Obstructive coronary artery disease

• Left ventricular ejection fraction ≤40% with evidence of heart failure, following myocardial infarction.

• eGFR <30 mL/ minute/1.73 m2

• Severe liver impairment

• Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test and who are unwilling or unable to follow the reproductive restrictions defined in the eligiblity criteria and use highly effective contraception as defined in Appendix 2 for the duration of the study treatment and 30 days after last dose of study drug.

• Patients taking one of the following medicines :

• Pre-existing treatment with an MRA :

• Anti-fungal drugs (ketoconazole or itraconazole).

• Antiviral medication (nelfinavir or ritonavir).

• Antibiotics (clarithromycin or telithromycin).

• Nefazodone used to treat depression.

• The combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB)) together.

Exclusion Criteria (registry):

• Contra-indication to cardiovascular magnetic resonance imaging e.g. severe claustrophobia, metallic foreign body.

• Contra-indication to intravenous adenosine, i.e. severe asthma; long QT syndrome; second- or third-degree atrio-ventricular block and sick sinus syndrome.

• Lack of informed consent.