Using eplerenone to treat heart injury in patients with small vessel disease
The Effect of Mineralocorticoid Receptor Antagonist Therapy in Patients With Acute Myocardial Infection or Injury and no Obstructive Coronary Arteries: a Registry-based, Stratified-medicine, Randomized, Controlled Trial
This study is testing if the medication eplerenone can help reduce heart damage and improve recovery for patients with heart injuries caused by small vessel disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NHS National Waiting Times Centre Board Academic / other |
| Locations | 2 sites (East Kilbride, Lanarkshire and 1 other locations) |
| Trial ID | NCT05198791 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of eplerenone, a mineralocorticoid receptor antagonist, in patients experiencing myocardial infarction or injury without obstructive coronary arteries, particularly focusing on those with small vessel disease. Patients will undergo coronary angiography to assess for blockages and will be stratified based on their microvascular function. Those identified with microvascular dysfunction will be randomized to receive either standard care or eplerenone therapy. The aim is to determine if eplerenone can reduce myocardial damage and improve outcomes in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced an acute myocardial infarction or myocardial injury without obstructive coronary arteries and have at least one cardiovascular risk factor.
Not a fit: Patients with obstructive coronary artery disease or severe heart failure are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and heart function in patients with myocardial injury caused by small vessel disease.
How similar studies have performed: Previous studies have shown promise in using mineralocorticoid receptor antagonists for similar conditions, but this specific approach in MINOCA is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. * Estimated glomerular filtration rate \<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 eligibility 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.
Where this trial is running
East Kilbride, Lanarkshire and 1 other locations
- University Hospital Hairmyres — East Kilbride, Lanarkshire, United Kingdom (Recruiting)
- Golden Jubilee National Hospital — Glasgow, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Colin Berry, PhD — University of Glasgow
- Study coordinator: Colin Berry, PhD
- Email: colin.berry@glasgow.ac.uk
- Phone: 01413303325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.