Actively Recruiting
BPA in CTEPD Without PH
Led by Amsterdam UMC, location VUmc · Updated on 2023-10-19
60
Participants Needed
1
Research Sites
228 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
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.
CONDITIONS
Official 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 New York Heart Association (NYHA) class 2 or higher
- Persistent radiological perfusion defects of 3 or more segmental perfusion defects
- Cardiopulmonary exercise test (CPET) showing at least two specific abnormal criteria related to oxygen uptake, pulse, ventilation, or oxygen saturation
- Exercise findings that cannot be explained by other causes
- Completed a pulmonary rehabilitation program of at least 8 weeks no longer than 2 months before randomization
- Exercise tests performed after the rehabilitation program
- Age between 18 and 80 years
- Clinical Frailty Scale score less than 5
- Written informed consent provided
- Prior treatment or restart of therapeutic dose anticoagulation treatment before randomization
You will not qualify if you...
- History of balloon pulmonary angioplasty (BPA) or pulmonary endarterectomy
- Residual blood clots that are not suitable for BPA
- Major acute or chronic heart or lung diseases impacting survival or exercise capacity, including pulmonary hypertension with mean pulmonary artery pressure 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 below 30 ml/min
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1117
Actively Recruiting
Research Team
A
Aleid Breuning, MD
CONTACT
J
Josien van Es, MD,PhD
CONTACT
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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