BPA in CTEPD Without PH

NCT06090838 | Recruiting DMC

• 1 other identifier: NL83240.018.23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Thromboembolic Disease

Outcome Measures

Primary Outcomes (1)

• disease specific quality of life

  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.

  baseline, 6 months, 12 months and 24 months

Secondary Outcomes (6)

• Change in max load in cardiopulmonary exercise test

  baseline, 6 and 12 months

• Change in oxygen uptake (VO2) in cardiopulmonary exercise test

  baseline, 6 and 12 months

• Change in O2 pulse in cardiopulmonary exercise test

  baseline, 6 and 12 months

• Change in oxygen saturation in cardiopulmonary exercise test

  baseline, 6 and 12 months

• Change in eqCO2 in exercise capacity in cardiopulmonary exercise test

  baseline, 6 and 12 months

Study Arms (2)

Intervention, BPA

EXPERIMENTAL

Will receive questionnaires, exercise testing and BPA at baseline, follow up with questionnaires and exercise testing will be done at 6,12 and 24 months.

Procedure: Balloon Pulmonary Angioplasty (BPA)

Control, no BPA

NO INTERVENTION

Will receive questionnaires, exercise testing at baseline. Due to the crossover design, they will receive BPA at 6 months. Follow up with questionnaires and exercise testing will be done at 6,12 and 24 months.

Interventions

Balloon Pulmonary Angioplasty (BPA) PROCEDURE

A balloon pulmonary angioplasty is a minimally invasive intervention procedure to remove blood clots from the pulmonary arteries.

Intervention, BPA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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

You may not qualify 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 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
• inability to undergo exercise tests
• contrast allergy
• creatinine clearance \< 30ml/min
• pregnancy or breastfeeding

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Trombosestichting Nederland: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1117, Netherlands

RECRUITING

Central Study Contacts

Aleid Breuning, MD

CONTACT

0031204444444; a.m.breuning@amsterdamumc.nl

Josien van Es, MD,PhD

CONTACT

0031204444444; j.vanes1@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: RCT with cross-over phase

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 19, 2023
• Study Start: June 15, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)