Balloon Pulmonary Angioplasty for Chronic Thromboembolic Disease

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

This study tests if Balloon Pulmonary Angioplasty can improve the quality of life and exercise ability for people with chronic thromboembolic pulmonary disease who don't have high blood pressure in their lungs.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Amsterdam UMC, location VUmc (other)
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT06090838 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of Balloon Pulmonary Angioplasty (BPA) on quality of life and exercise capacity in patients suffering from chronic thromboembolic pulmonary disease (CTEPD) without pulmonary hypertension. It employs a randomized, cross-over design where participants will first receive BPA treatment or serve as controls, followed by assessments of their quality of life and exercise performance. The study aims to determine the therapeutic effects of BPA and the optimal timing for the intervention, using various clinical assessments and questionnaires throughout the trial period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 with a history of acute pulmonary embolism and persistent functional limitations.

Not a fit: Patients with pulmonary hypertension or those who do not meet the specific inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and physical capabilities of patients with CTEPD.

How similar studies have performed: While there have been studies on BPA for other conditions, this specific approach for CTEPD without PH is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Amsterdam, North Holland

• Amsterdam UMC — Amsterdam, North Holland, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Aleid Breuning, MD

Conditions: Chronic Thromboembolic Disease