Active not recruitingNAINTERVENTIONAL

Endothelin Role In COronary Microcirculation

The ERICOM study is for people who experience chest pain, known as angina, but don’t have major blockages in their heart arteries. It focuses on a problem called coronary microvascular dysfunction, where the very small blood vessels in the heart don't work properly. Researchers are investigating whether a drug called bosentan, which targets a natural body chemical called endothelin-1, can help these tiny blood vessels function better. Endothelin-1 can make blood vessels constrict, and the study aims to see if blocking its action improves blood flow. Participants will have heart scans before and after taking the medication to check for improvements. The findings could lead to new treatments for this type of angina.

At a glance

Status

Active not recruiting

Phase

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Enrolment target

Start

01 Jul 2023

Estimated completion

01 Aug 2026

Coronary Microvascular Dysfunction (CMD)Angina Pectoris With Normal Coronary Arteriogram Microvascular Angina

What is this study about?

Many people experience chest pain (angina) even when the main arteries to their heart appear clear. This can be very worrying and frustrating. It's often due to an issue called coronary microvascular dysfunction (CMD), which means the tiny, unseen blood vessels within the heart muscle aren't working as they should. These small vessels are crucial for delivering oxygen and nutrients to the heart, so when they don't function properly, it can cause chest pain and other problems.

The ERICOM study is looking into a natural substance in the body called endothelin-1. We know that endothelin-1 can cause blood vessels to tighten, and previous research suggests it might play a role in why these tiny heart vessels don't work correctly in people with CMD. If we can understand this link better, it could open doors for new ways to treat this condition.

This study aims to discover if a specific medicine, bosentan, can help. Bosentan works by blocking the effects of endothelin-1. Researchers want to see if taking bosentan can improve how well these tiny heart blood vessels function. The results from this study could be very important, helping doctors better understand and treat angina when the main heart arteries are clear.

Key takeaways

This study explores a common cause of chest pain where main heart arteries are clear.
It investigates if a medication, bosentan, can improve how tiny heart blood vessels work.
The research aims to understand a natural body chemical called endothelin-1 and its role.
Participants will undergo scans before and after treatment to check for changes.
The findings could lead to new treatment options for angina due to microvascular dysfunction.
Participation involves medication for 4 weeks and heart scans.

Who may be eligible?

This study is looking for adults aged 18 or over who have ongoing chest pain (angina) that occurs with activity or stress and is relieved by rest or medication. It's specifically for people who have been told that their main heart arteries are not significantly blocked, suggesting their angina might be due to problems with the much smaller blood vessels in the heart.

There are several reasons why someone might not be able to join. For example, if your angina is getting much worse, is new and severe, or happens at rest, this study might not be suitable. It’s also not for people who have already been diagnosed with major blockages in their heart arteries (more than 50% narrowed) or have certain other health conditions like uncontrolled high blood pressure, severe heart failure, severe kidney or liver disease, or if you are pregnant or breastfeeding.

Additionally, if you have a known allergy to similar medications (endothelin receptor antagonists), are taking other medicines that shouldn't be combined with bosentan, or need a heart angiogram for another reason, you would not be able to take part. Your doctor will carefully review your medical history to see if this study is a good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you get chest pain (angina) with effort or stress?
Have you been told your main heart arteries are NOT significantly blocked?
Are you able and willing to follow study instructions and attend appointments?
Are you NOT pregnant or breastfeeding?
Do you NOT have severe problems with your heart, kidneys, or liver?

Answer every question to see your result.

What does participation involve?

If you join the ERICOM study, you will first have an initial health check-up, including a blood test. You will then have a special heart scan called a cardiac MRI, both at rest and after a 'stress' medication to see how your heart works under demand. You will then take the study medication, bosentan, every day for four weeks.

After four weeks, you will have another cardiac MRI scan to see if the medication has made any difference. Some participants will also have an invasive coronary angiogram, which is a procedure where doctors look directly at your heart's blood vessels using a small tube inserted into an artery, to get a more detailed look at the tiny vessels. The total duration of your active involvement in the study will be around 4-6 weeks.

Potential risks and benefits

Taking part in this study could potentially help us understand more about your condition and improve future treatments for angina caused by microvascular dysfunction. However, there are potential risks, such as side effects from the study medication (bosentan) which your doctor will discuss with you. There are also risks associated with the cardiac MRI scans and, for some, the invasive angiogram. You will be closely monitored throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

NHS University Hospitals of Liverpool Group
Verified postcode
Liverpool, United Kingdom

Common questions

What is angina?

Angina is a type of chest pain or discomfort that happens when your heart muscle isn't getting enough oxygen-rich blood. It often feels like a squeezing, pressure, heaviness, tightness, or pain in your chest.

What does 'coronary microvascular dysfunction' mean?

This means that the very small blood vessels within your heart muscle are not working as they should, even if your main heart arteries are clear. This can limit blood flow to your heart and cause symptoms like angina.

What is endothelin-1?

Endothelin-1 is a natural substance your body makes that can cause blood vessels to tighten. Researchers believe it might play a role in issues with the tiny heart blood vessels.

What is a cardiac MRI scan?

A cardiac MRI uses strong magnets and radio waves to create detailed pictures of your heart, helping doctors see how well it's working and measure blood flow.

Will taking part help me personally?

While the main goal is to learn more for future patients, some people might experience improvements in their symptoms during the study. However, this is not guaranteed, and you should not expect direct health benefits by participating.