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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Balloon Pulmonary Angioplasty (BPA)
Procedure/SurgeryA balloon pulmonary angioplasty is a minimally invasive intervention procedure to remove blood clots from the pulmonary arteries.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intervention, BPAExperimental treatment 1 intervention
Group B: Control, no BPANo intervention 0 interventions
Trial outcomes
Primary outcomes
1
disease specific quality of life
Quality of life, measured with PEmb-QoL The PEmb-QoL is a questionnaire which comprises 40 items and assesses disease-specific QoL during the previous 4 weeks in 6 dimensions: frequency of complaints, activity of daily life (ADL) limitations, work-related problems, social limitations, intensity of complaints, and emotional complaints. The total score is calculated taking into account the difference in total items. The minimum clinically important difference is 15 point.
Time frame
baseline, 6 months, 12 months and 24 monthsSecondary outcomes
1
Change in max load in cardiopulmonary exercise test
load in Watt measured at rest, anaerobic threshold and max capacity
Time frame
baseline, 6 and 12 months2
Change in oxygen uptake (VO2) in cardiopulmonary exercise test
VO2 measured in mL/min and mL/min/kg at rest, anaerobic threshold and max capacity
Time frame
baseline, 6 and 12 months3
Change in O2 pulse in cardiopulmonary exercise test
O2 pulse measured in VO2/HR measured in ML at rest, anaerobic threshold and max capacity
Time frame
baseline, 6 and 12 months4
Change in oxygen saturation in cardiopulmonary exercise test
spO2 measured in %, at rest, anaerobic threshold and max capacity
Time frame
baseline, 6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Amsterdam UMC, location VUmc
Lead sponsor
Trombosestichting Nederland
Collaborator
Source ClinicalTrials.gov