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Recruiting NCT04206852

Safety and Efficacy of Balloon Pulmonary Angioplasty in China

— Observational Chronic Thromboembolic Pulmonary Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Balloon pulmonary angioplasty.
Who it may be relevant to
Registry conditions: Chronic Thromboembolic Pulmonary Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Incidence of Treatment-Emergent Adverse Events of BPA procedure. [Time frame: From initiation of BPA to 3-12 months after last session]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Change of fibroblast activation protein inhibitor expression after BPA [Time frame: From initiation of BPA to 3-12 months after last session]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • center of pulmonary vascular disease, Fuwai hospital — Beijing
  • Chinese Academy of Medical Sciences Fuwai hospital — Beijing

Identifiers

NCT: NCT04206852 · BPA registry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗