Safety and Efficacy of Balloon Pulmonary Angioplasty in China

December 14, 2023 updated by: Chinese Pulmonary Vascular Disease Research Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Center of pulmonary vascular disease, Fuwai hospital
        • Contact:
        • Principal Investigator:
          • Zhihong Liu, MD,PhD
      • Beijing, China, 100037
        • Recruiting
        • Chinese Academy of Medical Sciences Fuwai Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chronic thromboembolic pulmonary hypertension patients admitted in hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization.
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
Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization.
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
Cardiac index (CI) in L/m^2 is obtained by right cardiac catheterization.
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
World Health Organization is obtained from electronic medical records.
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
World Health Organization is obtained from electronic medical records.
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
World Health Organization is obtained from electronic medical records.
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
Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test.
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
diffusing capacity for carbon monoxide in % is obtained from pulmonary function test
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
Change of fibroblast activation protein inhibitor expression after BPA
From initiation of BPA to 3-12 months after last session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Pulmonary Vascular Disease Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2018

Primary Completion (Estimated)

May 11, 2028

Study Completion (Estimated)

May 11, 2028

Study Registration Dates

First Submitted

October 26, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPA registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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