BPA in CTEPD Without PH

NCT06090838 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Amsterdam UMC, location VUmc

Phase

Not applicable

Started

2023-06-15

Last updated

2023-10-19

Condition(s) studied

Chronic Thromboembolic Disease

Investigational drug(s) / intervention(s)

Balloon Pulmonary Angioplasty (BPA)

Balloon Pulmonary Angioplasty (BPA): A balloon pulmonary angioplasty is a minimally invasive intervention procedure to remove blood clots from the pulmonary arteries.

Study 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) 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion 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: 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

Primary outcome measure(s)

disease specific quality of life — baseline, 6 months, 12 months and 24 months
Quality of life, measured with PEmb-QoL The PEmb-QoL is a questionnaire which comprises 40 items and assesses disease-specific QoL during the previous 4 weeks in 6 dimensions: frequency of complaints, activity of daily life (ADL) limitations, work-related problems, social limitations, intensity of complaints, and emotional complaints. The total score is calculated taking into account the difference in total items. The minimum clinically important difference is 15 point.

Trial sites (1)

Facility	City	Region	Status
Amsterdam UMC	Amsterdam	North Holland	Recruiting

More Amsterdam UMC, location VUmc trials in the Netherlands

Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis Starting soon

Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study) Recruiting

Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE) Recruiting

Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy Recruiting

Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06090838 on ClinicalTrials.gov ↗ ← All trials in the Netherlands