Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Recruiting

• Conditions: Chronic Thromboembolic Pulmonary Hypertension

• Registration Number: NCT04206852
• Lead Sponsor: Chinese Pulmonary Vascular Disease Research Group

Brief Summary

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.

Study Timeline

• Study Start: 2018-05-11
• Study First Submitted: 2019-10-26
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20
• Primary Completion: 2028-05-11
• Study Completion: 2028-05-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 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
2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
3. Not amenable to pulmonary endarterectomy
4. Willing to provide informed consent

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of cardiac index (CI) in L/m^2 caused by series of BPA.	From initiation of BPA to 3-12 months after last session	Cardiac index (CI) in L/m\^2 is obtained by right cardiac catheterization.
Change of diffusing capacity for carbon monoxide caused by series of BPA.	From initiation of BPA to 3-12 months after last session	diffusing capacity for carbon monoxide in % is obtained from pulmonary function test
Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA.	From initiation of BPA to 3-12 months after last session	Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization.
Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA.	From initiation of BPA to 3-12 months after last session	World Health Organization is obtained from electronic medical records.
Change of World Health Organization (WHO) functional capacity classification caused by series of BPA.	From initiation of BPA to 3-12 months after last session	World Health Organization is obtained from electronic medical records.
Incidence of Treatment-Emergent Adverse Events of BPA procedure.	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.
Change of Pulmonary artery pressure in mmHg caused by series of BPA.	From initiation of BPA to 3-12 months after last session	Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization.
Change of six minutes walk distance in meter caused by series of BPA.	From initiation of BPA to 3-12 months after last session	World Health Organization is obtained from electronic medical records.
Change of Peak VO2/kg in ml/min/kg caused by series of BPA.	From initiation of BPA to 3-12 months after last session	Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test.
Change of fibroblast activation protein inhibitor expression after BPA	From initiation of BPA to 3-12 months after last session	Change of fibroblast activation protein inhibitor expression after BPA

Trial Locations

Locations (2)

center of pulmonary vascular disease, Fuwai hospital; 🇨🇳 Beijing, China

Chinese Academy of Medical Sciences Fuwai hospital; 🇨🇳 Beijing, China