RecruitingNAINTERVENTIONAL

BPA vs. PEA in CTEPH

This study is looking at a rare but serious lung condition called Chronic Thromboembolic Pulmonary Hypertension (CTEPH). This condition happens when blood clots block the blood vessels in the lungs. The usual treatment is a surgery called pulmonary endarterectomy (PEA). However, some people can't have surgery. For them, a different procedure called balloon pulmonary angioplasty (BPA) can be an option. This research is comparing these two treatments in patients who could have either surgery or BPA. The main goal is to find out if BPA is just as good as PEA in improving health by looking at how well blood flows through the lungs.

At a glance

Status

Recruiting

Phase

Sponsor

University of Aarhus

Enrolment target

139

Start

01 Apr 2024

Estimated completion

01 Apr 2028

Chronic Thromboembolic Pulmonary Hypertension

What is this study about?

This study is about a rare but serious lung condition called Chronic Thromboembolic Pulmonary Hypertension, or CTEPH. This condition develops when old blood clots that should have dissolved don't, and instead, they block or narrow the blood vessels in your lungs. This makes it harder for your heart to pump blood through your lungs, potentially leading to serious health issues.

The usual and most effective treatment for CTEPH is a major operation called pulmonary endarterectomy (PEA). This surgery is performed by specialist heart and lung surgeons to remove the old clot material from the blood vessels in the lungs. However, some patients might not be able to have this surgery. This could be because they have other health problems, or because the blockages in their lungs are in very tiny, hard-to-reach blood vessels. For these patients, a newer, less invasive procedure called balloon pulmonary angioplasty (BPA) has become available. During BPA, tiny balloons are used to open up the narrowed blood vessels.

There are also some patients where it's possible to do either the surgery (PEA) or the balloon procedure (BPA). Doctors don't currently know which of these is better or if they are equally effective in this specific group. This study aims to find out if BPA is as good as PEA in improving how well blood flows through the lungs for those patients who are suitable for both treatments. This information will help doctors choose the best treatment for their patients in the future.

Key takeaways

This study compares two treatments for a rare lung condition called CTEPH.
It aims to see if a non-surgical treatment (BPA) is as good as surgery (PEA).
It's for people who could safely have either treatment option.
Participants will be randomly chosen for one of the two treatments.
The study will follow participants for 12 months with specific medical tests.

Who may be eligible?

To be part of this study, you would need to have been diagnosed with CTEPH according to specific medical guidelines. Importantly, expert teams of doctors would need to agree that both the surgery (PEA) and the balloon procedure (BPA) are suitable options for you. You would also need to be between 18 and 79 years old and be able to understand and follow the study instructions.

You wouldn't be able to join the study if you have other serious health problems that significantly contribute to your lung condition, or if doctors believe you have less than a year to live. People who have had PEA or BPA before, or women who are pregnant or planning to become pregnant, would also not be able to participate. Also, if there's a strong chance your current lung medication would need to be changed during the first few months of the study, you might not be eligible.

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.

Do you have a confirmed diagnosis of CTEPH?
Have your doctors said both PEA surgery and BPA are possible for you?
Are you between 18 and 79 years old?
Are you able to attend appointments and follow study instructions?
Have you *not* had PEA or BPA treatment before?
Are you not pregnant or planning to be?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the PEA surgery or a series of BPA procedures. This decision will be made by chance, like flipping a coin. You will have your chosen treatment within six months of starting the study. Before your treatment, and again at four months and twelve months after your treatment (or your last BPA session if you have multiple), you will have special heart and lung tests, including a procedure called a right heart catheterisation. This involves a thin tube being inserted into a blood vessel, usually in your neck or groin, and guided into your heart to measure pressures. You will have regular contact with the study team throughout the year to monitor your health and progress.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a closely monitored treatment for your CTEPH under expert care. While both PEA and BPA are established treatments, this study aims to understand their comparative effectiveness for a specific group of patients. Potential risks are associated with the medical procedures themselves (PEA or BPA), which your doctor will explain in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Aarhus University Hospital
Verified postcode
Aarhus, Denmark· Recruiting
Royal Ppworth
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is CTEPH?

CTEPH is a rare but serious lung condition where old blood clots block blood vessels in the lungs, making it hard for the heart to pump blood.

What's the difference between PEA and BPA?

PEA is a surgical operation to remove blood clots from the lungs. BPA is a non-surgical procedure using balloons to open up blocked blood vessels in the lungs.

Why is this study important?

This study will help doctors understand whether BPA is as effective as surgery (PEA) for patients who could have either treatment, helping them make better choices for future patients.

Will I get to choose my treatment?

No, if you join the study, you will be randomly assigned to either PEA or BPA, like drawing lots or flipping a coin.

What is a 'right heart catheterisation'?

It's a medical test where a small tube is carefully guided into your heart to measure pressures, helping doctors check how well your heart and lungs are working.

How to find out more

Asger Andersen, MD, ass.prof.

asger.andersen@clin.au.dk 40138052 Official trial record

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