Safety and Efficacy of Balloon Pulmonary Angioplasty in China

• Sponsor: Chinese Pulmonary Vascular Disease Research Group (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04206852
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 120
• Patients Per Site: 100
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Thromboembolic Pulmonary Hypertension	Procedure: Balloon pulmonary angioplasty

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Safety and Efficacy of Balloon Pulmonary Angioplasty in China
• Actual Study Start Date: May 11, 2018
• Anticipated Primary Completion Date: May 11, 2028
• Anticipated Study Completion Date: May 11, 2028

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	center of pulmonary vascular disease, Fuwai hospital	Beijing		China	100037
2	Chinese Academy of Medical Sciences Fuwai hospital	Beijing		China	100037

Sponsors and Collaborators

• Chinese Pulmonary Vascular Disease Research Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chinese Pulmonary Vascular Disease Research Group
• ClinicalTrials.gov Identifier: NCT04206852
• Other Study ID Numbers: BPA registry
• First Posted: Dec 20, 2019
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension, Pulmonary

Study Results

No Results Posted as of Aug 20, 2021