Active not recruitingOBSERVATIONAL

TrEatment Approach in the Multimodal Era Registry

This study is like a detailed look at how specialist centres in the UK treat a serious lung condition called Chronic Thromboembolic Pulmonary Hypertension (CTEPH). In CTEPH, old blood clots block blood vessels in the lungs, making it hard to breathe. Doctors want to understand which treatments – a surgery to remove clots, a balloon procedure to open vessels, or special medications – are used, and how these are combined. The main goal is to see how different treatments affect patients' health and how long they live over time. Patients in this study will get the same care they would normally receive; they won't be given any experimental treatments. Instead, doctors will simply collect information about their health and treatment journey as part of their routine appointments. This helps improve care for all CTEPH patients.

At a glance

Status

Active not recruiting

Sponsor

International CTEPH Association

Enrolment target

1,000

Start

12 Apr 2023

Estimated completion

01 Apr 2028

Chronic Thromboembolic Pulmonary Hypertension CTEPH

What is this study about?

Imagine your lungs have tiny pipes (blood vessels) that carry blood. If these pipes get blocked by old blood clots, it makes your heart work much harder and you can become very breathless. This condition is called Chronic Thromboembolic Pulmonary Hypertension, or CTEPH.

Doctors have different ways to clear these blocked pipes: a special operation to remove clots (called pulmonary endarterectomy or PEA), a procedure using a tiny balloon to open up smaller blockages (called balloon pulmonary angioplasty or BPA), or taking special medicines. Sometimes, a combination of these treatments works best. Because CTEPH can be complex, experts want to learn more about how the very best centres treat patients in real life.

This study is not about trying new treatments. Instead, it's about watching and learning from how expert doctors currently treat CTEPH. They want to understand which treatments are used most often, how doctors decide which combination of treatments is best, and most importantly, how patients are doing after these treatments. By gathering this information, they hope to improve care for everyone with CTEPH in the future.

Key takeaways

It's a study looking at current CTEPH treatments, not testing new ones.
Your care won't change if you join.
Doctors will collect information from your usual appointments.
The goal is to improve care for all CTEPH patients.
Participation lasts at least 3 years.
Your decision to join or leave the study won't affect your treatment.

Who may be eligible?

To join this study, you would typically need to have been recently diagnosed with CTEPH or a related condition called chronic thromboembolic pulmonary disease (CTEPD, which is similar but without high blood pressure in the lungs). Your doctor would need to confirm your diagnosis using scans or tests that show blood clots blocking vessels in your lungs.

It's important that you've been on blood-thinning medication (anticoagulation) for at least three months before your CTEPH diagnosis. Also, you shouldn't have had the specific surgery (PEA) or balloon procedure (BPA) for this condition before. If you've been on some specific CTEPH medicines, it should only have been for a short time (less than 12 months), or not at all. You also need to be 18 years old or over, and your main lung problem cannot be caused by something else.

The most important thing is that you're willing to give your permission to be part of the study, and that your CTEPH treatment journey will be managed by the expert hospital taking part in this study.

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.

I have been recently diagnosed with CTEPH or a related condition where blood clots block lung vessels.
My doctor has confirmed this diagnosis with scans or tests.
I have been taking blood-thinning medicine for at least 3 months.
I have not had the special surgery (PEA) or balloon procedure (BPA) for CTEPH before.
I am 18 years old or older.
I am willing for my expert care team to share my health information for this valuable research.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't need to do anything differently than you would for your usual care. You'll continue to visit your doctors, nurses, and hospital for your routine appointments and treatments for CTEPH, exactly as planned by your medical team.

During these regular visits, your doctors and nurses will simply collect information about your health, your treatment plan, and how you are responding. This information, which they would normally record anyway, will then be entered into a secure study database. There will be no extra tests, appointments, or medications that you wouldn't already be having.

The study will follow your health journey for at least three years. This means they'll gather updates on your condition and treatment during your normal check-ups over that period to understand the long-term effects of care.

Potential risks and benefits

Participating in this study means you'll be contributing to a better understanding of CTEPH and how best to treat it, which could help future patients. You won't receive experimental treatments; you'll get the standard care your doctor recommends, and there are no additional tests or visits beyond what you would usually have. This means there are no extra risks to your health by joining the study. Your information will be kept confidential. Remember, you can decide to stop being part of the study at any time without it affecting your medical care.

Locations (25)

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

University of California San Diego
Verified postcode
San Diego, United States
Northwestern University
Verified postcode
Evanston, United States
Duke University
Verified postcode
Durham, United States
UT Southwestern
Verified postcode
Dallas, United States
Hospital Universitario Fundación Favaloro
Verified postcode
Buenos Aires, Argentina
University Hospital Vienna
Verified postcode
Vienna, Austria
University Hospitals Leuven
Verified postcode
Leuven, Belgium
Santa Casa
Verified postcode
Porto Alegre, Brazil
Toronto General Hospital
Verified postcode
Toronto, Canada
China-Japan Friendship Hospital
Verified postcode
Beijing, China
Shaio Clinic Foundation
Verified postcode
Bogotá, Colombia
General University Hospital
Verified postcode
Prague, Czechia

Common questions

What is CTEPH?

It's a serious lung condition where old blood clots block blood vessels in your lungs, making it hard to breathe and putting a strain on your heart.

Will I get different treatment if I join this study?

No, you'll receive the exact same treatments and care that your doctors would normally recommend for your condition, whether or not you join the study.

What do I have to do if I take part?

You just continue to attend your regular hospital appointments. Your doctors will collect information about your health during these visits, which they do anyway.

How long will I be in the study?

The study will follow your health and treatment journey for at least three years, gathering information during your normal check-ups.

Is my personal information safe?

Yes, all your health information collected for the study will be kept private and confidential.