BPA in CTEPD Without PH
ConditionChronic Thromboembolic Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAmsterdam UMC, location VUmc
About this trial
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 criteria
Qualifiers
acute pulmonary embolism at least 3 months prior to inclusion and adequately treated
persistent functional limitations: (New York Heart Association (NYHA) class ≥2)
persistent radiological perfusion defects: ≥ 3 segmental perfusion defects
peak VO2 < 80%;
Disqualifiers
history of balloon pulmonalis angiography (BPA) or pulmonary endarterectomy
residual thrombi that are not eligible for BPA
major acute or chronic cardiopulmonary comorbidities with an expected impact on survival, exercise capacity and/or gas exchange, e.g. significant coronary heart disease, diastolic/systolic heart failure, pulmonary hypertension (mPAP > 25 mmHg), severe chronic obstructive pulmonary disease (COPD) GOLD class ≥3, interstitial lung disease (ILD), disabling neuromuscular disease, malignancy
inability to undergo exercise tests
Trial design
Treatments tested in this trial
- Balloon Pulmonary Angioplasty (BPA)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Amsterdam UMC, location VUmc
Lead sponsor
Trombosestichting Nederland
Collaborator
Source ClinicalTrials.gov