Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:

Safety and Efficacy of Balloon Pulmonary Angioplasty in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04206852
• Other study ID #: BPA registry
• Status: Recruiting
• Start date: May 11, 2018
• Est. completion date: May 11, 2028

Study information

• Verified date: December 2023
• Source: Chinese Pulmonary Vascular Disease Research Group
• Contact: Zhihong Liu, doctor
• Phone: 86-010-88396589
• Email: zhihongliufuwai[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 11, 2028
• Est. primary completion date: May 11, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension, Pulmonary

Intervention

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.

Locations

Country	Name	City	State
China	center of pulmonary vascular disease, Fuwai hospital	Beijing
China	Chinese Academy of Medical Sciences Fuwai hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Pulmonary Vascular Disease Research Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events of BPA procedure.	Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death.	From initiation of BPA to 3-12 months after last session
Primary	Change of Pulmonary artery pressure in mmHg caused by series of BPA.	Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization.	From initiation of BPA to 3-12 months after last session
Primary	Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA.	Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization.	From initiation of BPA to 3-12 months after last session
Primary	Change of cardiac index (CI) in L/m^2 caused by series of BPA.	Cardiac index (CI) in L/m^2 is obtained by right cardiac catheterization.	From initiation of BPA to 3-12 months after last session
Primary	Change of World Health Organization (WHO) functional capacity classification caused by series of BPA.	World Health Organization is obtained from electronic medical records.	From initiation of BPA to 3-12 months after last session
Primary	Change of six minutes walk distance in meter caused by series of BPA.	World Health Organization is obtained from electronic medical records.	From initiation of BPA to 3-12 months after last session
Primary	Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA.	World Health Organization is obtained from electronic medical records.	From initiation of BPA to 3-12 months after last session
Primary	Change of Peak VO2/kg in ml/min/kg caused by series of BPA.	Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test.	From initiation of BPA to 3-12 months after last session
Primary	Change of diffusing capacity for carbon monoxide caused by series of BPA.	diffusing capacity for carbon monoxide in % is obtained from pulmonary function test	From initiation of BPA to 3-12 months after last session
Primary	Change of fibroblast activation protein inhibitor expression after BPA	Change of fibroblast activation protein inhibitor expression after BPA	From initiation of BPA to 3-12 months after last session