BPA in CTEPD Without PH
Recruiting · NCT06090838 · Interventional (participants receive a specific treatment) · Lead sponsor: Amsterdam UMC, location VUmc
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- CPET result with:
- at least 2 of the following criteria:
- peak VO2 \< 80%;
- peak O2 pulse \< 80% of predicted;
- V'E/V'CO2 @ nadir \> 34;
- Vd/Vt increasing until peak exercise or peak Vd/Vt \> 0;4;
- gradual drop of SpO2 of ≥ 3%;
- these exercise findings cannot be explained otherwise 2. patients completed a pulmonary rehabilitation program of at least 8 weeks no longer than 2 months before randomization.
- \. exercise tests were performed after the pulmonary rehabilitation program 4. age 18-80 years 5. Clinical Frailty Scale (CFS) score \< 5 (CFS is a 9-point scale that summarizes the overall level of fitness or frailty of an older adult) 6. written informed consent 7. prior treatment or restart therapeutic dose of anticoagulation treatment before randomization
Exclusion criteria
- 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
- contrast allergy
- creatinine clearance \< 30ml/min
- pregnancy or breastfeeding
Where it is running
1 location listed.
- Amsterdam UMC - Amsterdam, North Holland, Netherlands