Status:
RECRUITING
BPA in CTEPD Without PH
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Trombosestichting Nederland
Conditions:
Chronic Thromboembolic Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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)...
Detailed Description
BALLOON-TRIAL is a mono-center, prospective, open-label, randomized clinical trial with PROBE design. By adopting a cross-over part, all patients are eventually offered Balloon Pulmonary Angioplasty (...
Eligibility Criteria
Inclusion
- 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.
- 3\. 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
- 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
Key Trial Info
Start Date :
June 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06090838
Start Date
June 15 2023
End Date
October 31 2027
Last Update
October 19 2023
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1117