Using eplerenone to treat heart injury in patients with small vessel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.