NCT06090838Recruiting

BPA in CTEPD Without PH

Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Disease Without or With Mild Pulmonary Hypertension

Source: ClinicalTrials.gov · Last updated 19 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 11 Sept 2023
Start date: 15 Jun 2023
Primary completion date: 31 Oct 2025
Lead sponsor: Amsterdam UMC, location VUmc
Diseases: Pulmonary arterial hypertension, High blood pressure
NCT number: NCT06090838

What you commit to

Study type: Interventional
Planned participants: 60
From 15 Jun 2023 to the primary completion date, 31 Oct 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

persistent functional limitations: (New York Heart Association (NYHA) class ≥2)
persistent radiological perfusion defects: ≥ 3 segmental perfusion defects
CPET result with: 1. 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%; 2. 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 Criteria: 1. history of balloon pulmonalis angiography (BPA) or pulmonary endarterectomy 2. residual thrombi that are not eligible for BPA 3. 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 4. inability to undergo exercise tests 5. contrast allergy 6. creatinine clearance \< 30ml/min 7. pregnancy or breastfeeding

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Amsterdam UMC Coordinator of this site? Confirm its status	Amsterdam	Netherlands	Recruiting

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