Balloon Pulmonary Angioplasty for Chronic Thromboembolic Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amsterdam UMC
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Aleid Breuning, MD
• Email: a.m.breuning@amsterdamumc.nl
• Phone: 0031204444444

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for patients with chronic thromboembolic disease

  This study is collecting information from patients with chronic thromboembolic disease to see how different treatments affect their health and quality of life over time.

  Recruiting University of California, San Francisco · San Francisco, California · NCT05843500

• Using AI to improve imaging for pulmonary embolism diagnosis

  This study is testing if using advanced imaging and artificial intelligence can help doctors diagnose and manage pulmonary embolism better for patients who might have it.

  Recruiting China-Japan Friendship Hospital · Beijing · NCT06526468

• Pulmonary Embolism Registry from Emergency Care to Long-Term Follow-Up

  This registry follows adults with acute pulmonary embolism to see how care is given in the real world and what happens over time.

  Recruiting at 16 sites Azienda Ospedaliero-Universitaria Careggi · Bagno a Ripoli, Tuscany and 15 other locations · NCT07855679

• Nailfold Capillaroscopy in Pulmonary Hypertension

  This study tests whether nailfold capillary scans correlate with invasive lung blood pressure measurements and whether these patterns change with PH treatment.

  Recruiting University of Glasgow · Clydebank, West Dunbartonshire · NCT07768644

• How pulmonary endarterectomy affects confidence in managing chronic thromboembolic pulmonary hypertension

  This project will see if pulmonary endarterectomy helps people with chronic thromboembolic pulmonary hypertension feel more confident managing their condition.

  Recruiting Damascus University · Damascus, Rif-dimashq Governorate · NCT07272798

• Registry of people with chronic thromboembolic pulmonary hypertension in Russia

  This registry collects health, history, and treatment information from people in Russia with chronic thromboembolic pulmonary hypertension to see which factors relate to their prognosis.

  Recruiting National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Moscow · NCT07254078

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.