RecruitingNot ApplicableNCT06090838

BPA in CTEPD Without PH

Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Disease Without or With Mild Pulmonary Hypertension


Sponsor

Amsterdam UMC, location VUmc

Enrollment

60 participants

Start Date

Jun 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess the effect of Balloon Pulmonary Angioplasty (BPA) on quality of life and exercise capacity in patients with chronic tromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH). The main question\[s\] it aims to answer are: * What is the effect of BPA on quality of life, measured with the PEmb-QoL-questionnaire, in patients with CTEPD without PH? * What is the effect of is the effect of BPA on exercise capacity in patients with CTEPD without PH? This study is a randomised clinical trial with cross-over design. Participants will be randomised in an intervention and a control group. At baseline, questionnaires and exercise tests will be perfomed in all patients. The intervention group will first receive BPA-treatment. After 6 months, all patients will fill in the questionaires and undergo the exercise tests. At this point the control group will also receive BPA-treatment. After 12 months the study outcomes will be measured in all participants with the same questionnaires and exercise tests. The total follow-up is 24 months.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing balloon pulmonary angioplasty (BPA) — a procedure that opens up blocked or narrowed blood vessels in the lungs — for people who had a pulmonary embolism (a blood clot in the lungs) and still have breathing and exercise problems months or years later, even though their blood pressure in the lungs is not yet elevated. This condition is called chronic thromboembolic pulmonary disease (CTEPD) without pulmonary hypertension. **You may be eligible if...** - You had a pulmonary embolism at least 3 months ago and received appropriate treatment - You still have significant shortness of breath and exercise limitations (NYHA class 2 or higher) - Imaging shows persistent blood flow problems in your lungs - Exercise testing confirms abnormal breathing patterns that cannot be explained by another condition - You completed at least 8 weeks of pulmonary rehabilitation within the past 2 months - You are between 18 and 80 years old and not severely frail **You may NOT be eligible if...** - Your lung blood vessel problems have resolved - You are very frail (CFS score 5 or higher) - You have elevated pulmonary arterial pressure (that would be diagnosed as pulmonary hypertension) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBalloon Pulmonary Angioplasty (BPA)

A balloon pulmonary angioplasty is a minimally invasive intervention procedure to remove blood clots from the pulmonary arteries.


Locations(1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

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NCT06090838


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