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NCT Number: NCT04206852

Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Balloon pulmonary angioplasty (BPA) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).

The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA.

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Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese Academy of Medical Sciences Fuwai hospital, Beijing, China

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About this study

This study is a prospective, multi-center, long-term observational project to study the safety and efficacy of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, biomarkers, cardiopulmonary exercise test, electrocardiography, echocardiography, haemodynamics, pulmonary angiography and lung scintigraphy was performed before the initiation therapy of BPA, and 3-12 months after last session of BPA.

we also aim to evaluate the value of FAPI in predicting the efficacy and the prognosis of patients with CTEPH who received BPA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP < 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
  • Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
  • Not amenable to pulmonary endarterectomy
  • Willing to provide informed consent

Exclusion criteria

  • Patients unwilling or unable to provide written consent for participation in the study.
  • Impossible to follow up.

Treatment and study plan

Balloon pulmonary angioplasty

Procedure

Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.

Other names: BPA

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events of BPA procedure.

    Time frame: From initiation of BPA to 3-12 months after last session

    Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death.

  2. Change of Pulmonary artery pressure in mmHg caused by series of BPA.

    Time frame: From initiation of BPA to 3-12 months after last session

    Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization.

  3. Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA.

    Time frame: From initiation of BPA to 3-12 months after last session

    Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization.

  4. Change of cardiac index (CI) in L/m^2 caused by series of BPA.

    Time frame: From initiation of BPA to 3-12 months after last session

    Cardiac index (CI) in L/m^2 is obtained by right cardiac catheterization.

  5. Change of World Health Organization (WHO) functional capacity classification caused by series of BPA.

    Time frame: From initiation of BPA to 3-12 months after last session

    World Health Organization is obtained from electronic medical records.

  6. Change of six minutes walk distance in meter caused by series of BPA.

    Time frame: From initiation of BPA to 3-12 months after last session

    World Health Organization is obtained from electronic medical records.

  7. Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA.

    Time frame: From initiation of BPA to 3-12 months after last session

    World Health Organization is obtained from electronic medical records.

  8. Change of Peak VO2/kg in ml/min/kg caused by series of BPA.

    Time frame: From initiation of BPA to 3-12 months after last session

    Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test.

  9. Change of diffusing capacity for carbon monoxide caused by series of BPA.

    Time frame: From initiation of BPA to 3-12 months after last session

    diffusing capacity for carbon monoxide in % is obtained from pulmonary function test

  10. Change of fibroblast activation protein inhibitor expression after BPA

    Time frame: From initiation of BPA to 3-12 months after last session

    Change of fibroblast activation protein inhibitor expression after BPA

Study contacts

Contact information is provided by the study sponsor or research team.

Zhihong Liu, doctor

CONTACT

[email protected]

86-010-88396589

Sponsors and collaborators

Lead sponsor

Chinese Pulmonary Vascular Disease Research Group

Other

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Dec 20, 2019
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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