Actively Recruiting
Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Disease Without or With Mild Pulmonary Hypertension
Led by Amsterdam UMC, location VUmc · Updated on 2023-10-19
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
T
Trombosestichting Nederland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Balloon Pulmonary Angioplasty (BPA) on quality of life and exercise capacity in patients with chronic thromboembolic pulmonary disease (CTEPD) who do not have pulmonary hypertension (PH). This randomized clinical trial uses a cross-over design to compare BPA treatment against standard care without intervention. The study aims to understand how BPA impacts patient-reported quality of life and physical performance over time. Participants are randomly assigned to either receive BPA treatment immediately or continue with standard care initially. At baseline, all participants complete questionnaires and exercise tests. The intervention group receives BPA first, followed by evaluations at 6, 12, and 24 months. After 6 months, the control group also receives BPA, allowing all participants to eventually undergo treatment. The study is open-label, but the primary outcome assessment is blinded. During the study, patients will complete quality of life questionnaires and undergo cardiopulmonary exercise testing at baseline and several follow-up points. Additional assessments include blood tests, imaging, and functional tests as part of clinical care before enrollment. Patient outcomes are measured at 6, 12, and 24 months, focusing on exercise capacity changes and disease-specific quality of life. The total follow-up period for participants is 24 months, with ongoing monitoring of symptoms and physical performance.
CONDITIONS
Brief Title
BPA in CTEPD Without PH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute pulmonary embolism at least 3 months prior to inclusion and adequately treated
- Persistent functional limitations with NYHA class 2 or higher
- Persistent radiological perfusion defects of 3 or more segmental defects
- Cardiopulmonary exercise test showing at least 2 specific abnormal criteria
- Completion of a pulmonary rehabilitation program of at least 8 weeks within 2 months before randomization
- Exercise tests performed after rehabilitation
- Age between 18 and 80 years
- Clinical Frailty Scale score less than 5
- Written informed consent
- Prior treatment or restart of therapeutic dose anticoagulation before randomization
You will not qualify if you...
- History of balloon pulmonary angioplasty or pulmonary endarterectomy
- Residual clots not eligible for BPA
- Major acute or chronic heart or lung diseases affecting survival or exercise capacity including pulmonary hypertension with mPAP over 25 mmHg, severe COPD GOLD class 3 or higher, interstitial lung disease, disabling neuromuscular disease, or cancer
- Inability to perform exercise tests
- Allergy to contrast agents
- Creatinine clearance less than 30 ml/min
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 months
Participants are randomized to either receive Balloon Pulmonary Angioplasty (BPA) or standard care without intervention. Those assigned to BPA undergo the minimally invasive procedure to remove blood clots from the pulmonary arteries.
Visits for BPA treatment at baseline and additional visits depending on treatment schedule
Duration - 6 months
Participants initially assigned to standard care cross over to receive Balloon Pulmonary Angioplasty (BPA) after 6 months. BPA is performed according to the same treatment protocol as the initial BPA group.
Visits for BPA treatment after crossover
Duration - 6 months
Participants are followed for 6 months after the last BPA procedure to monitor recovery and assess outcomes including questionnaires and exercise testing.
Follow-up visits with questionnaires and exercise testing at 6, 12, and 24 months after randomization
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1117
Actively Recruiting
Research Team
A
Aleid Breuning, MD
J
Josien van Es, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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