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New treatment option for Chronic Thromboembolic Disease
Official title BPA in CTEPD Without PH
ClinicalTrials.gov ID: NCT06090838
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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:
You likely can't join if
- 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...
- inability to undergo exercise tests
- contrast allergy
- creatinine clearance \< 30ml/min
See the full eligibility 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. 3\. exercise tests were performed after...
- 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...
- inability to undergo exercise tests
- contrast allergy
- creatinine clearance \< 30ml/min
- pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.