RecruitingPHASE2INTERVENTIONAL

Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

This study is for people who have had a heart attack or heart injury but whose main heart arteries aren't blocked. Sometimes, damage can happen in the tiny blood vessels of the heart instead, called 'coronary microvascular dysfunction.' We want to see if a medication called eplerenone can help reduce this heart damage. Participants will have tests to check their tiny heart vessels. If these vessels are damaged, they might be offered eplerenone or standard care. Everyone will have blood tests and heart scans. The information gathered will help doctors better understand and treat this specific heart condition in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

NHS National Waiting Times Centre Board

Enrolment target

400

Start

04 Feb 2022

Estimated completion

31 Jul 2026

Myocardial Infarction, Acute Myocardial Infarction With Nonobstructive Coronary Arteries Myocardial Injury

What is this study about?

Imagine your heart is a house and the main roads leading to it are clear. But what if the small paths and alleys within the house's garden are damaged? This study looks at a similar situation in the heart. Some people have a heart attack or injury, but when doctors check their main heart arteries, they find no major blockages. Instead, the problem might be with the very small blood vessels within the heart muscle, a condition called 'coronary microvascular dysfunction.'

We already know a medicine called eplerenone can help protect the heart and is used for conditions like high blood pressure and heart failure. This study wants to find out if eplerenone can also help people who have heart damage because of problems with these tiny blood vessels. By understanding who might benefit most from this medicine, doctors can offer more targeted and effective treatments in the future.

This research will help us improve how we treat people with heart conditions. We also want to learn more about the different types of heart attacks where main arteries aren't blocked. By collecting information and samples, we can build a valuable resource for future studies, which will ultimately lead to better care for patients.

Key takeaways

This study is for people with heart attack/injury but no main artery blockages.
It focuses on damage to tiny heart blood vessels (microvascular dysfunction).
We're testing a drug called eplerenone for its heart-protective effects.
Participation involves heart tests, blood tests, and MRI scans.
The study helps doctors understand and treat this specific heart problem better.

Who may be eligible?

You might be able to join this study if you are 18 years or older and have recently had a heart attack or heart injury, but your main heart arteries are not blocked. You would also need to have at least one common risk factor for heart problems, like being over 70, having diabetes, high blood pressure, or a history of smoking.

There are some reasons why you might not be able to join. For example, if you have severe kidney problems, certain liver conditions, or if you are pregnant or breastfeeding. Also, if you're taking specific medications that might react badly with the study drug, you wouldn't be able to participate. This includes certain anti-fungal, antiviral, or antibiotic drugs, and some combinations of blood pressure medicines.

Before taking part, doctors will check if you have any conditions that would make it unsafe for you to have certain study tests, like a specific type of heart scan (MRI) or a small vessel assessment (adenosine infusion). Your doctor will talk with you about all these points to see if the study is right for you.

Quick self-check

Are you 18 years or older?
Have you recently had a heart attack or heart injury, but doctors said your main heart arteries aren't blocked?
Do you have at least one common heart risk factor (like being over 70, diabetes, high blood pressure, or a smoker)?
Are you able to have a heart procedure called an angiogram?
Are you NOT pregnant or breastfeeding?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have a heart procedure called an angiogram, where doctors will check both your main arteries and tiny blood vessels. If they find problems with your tiny vessels, you might be offered to join the main part of the study. You'd then either continue with your usual care or take eplerenone tablets every day for six months.

Throughout the study, you'll have several check-ups. This will include blood tests during your hospital stay, and then again at one month and six months. You'll also have a heart scan (MRI) at the start and after six months to check your heart function. We'll ask you to fill out some questionnaires about your health, and with your permission, we'll keep track of your long-term health using confidential medical records. We may also ask to store some of your blood samples for future research, which would help us learn even more about heart conditions. The total duration of active participation involving medication and follow-up tests would be six months.

Potential risks and benefits

Taking part in this study could help us learn more about your heart condition and how to treat it, which might benefit future patients. For those who receive eplerenone, there's a chance the medication could help reduce ongoing heart damage. However, like all medications, eplerenone can have side effects, and some people may find hospital visits or tests uncomfortable. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

University Hospital Hairmyres
East Kilbride, United Kingdom· Recruiting
Golden Jubilee National Hospital
Glasgow, United Kingdom· Recruiting

Common questions

What is 'microvascular dysfunction'?

It means the very tiny blood vessels in your heart aren't working as they should, even if your main heart arteries are clear.

What is eplerenone?

It's a medication that helps protect the heart and is used for conditions like high blood pressure and heart failure. We're testing if it helps with tiny vessel damage.

Will I definitely get the study drug?

Not necessarily. If your tiny blood vessels are affected, you might either get the study drug or continue with standard care, chosen at random.

How long will I be in the study?

Active participation with medication and tests will last for about six months. We'll also track your health long-term using medical records.

What if I change my mind about participating?

You can decide to stop participating at any time without needing to give a reason, and it won't affect your medical care.

How to find out more

Colin Berry, PhD

colin.berry@glasgow.ac.uk 01413303325 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.