Clinical Trial

BPA in CTEPD Without PH

Study acronym: BALLOON
Recruiting
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Record status
This record was last updated October 19, 2023 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06090838
Lead Sponsor Amsterdam UMC, location VUmc
Collaborators: Trombosestichting Nederland
Conditions Chronic Thromboembolic Disease
Enrollment 60 participants
Start Date 2023-06-15
Primary Completion 2025-10-31 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2023-10-19