NCT04206852

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
May 2018May 2028

Study Start

First participant enrolled

May 11, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2028

Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

10 years

First QC Date

October 26, 2019

Last Update Submit

December 14, 2023

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

Balloon pulmonary angioplastyPROCEDURE

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

Also known as: BPA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic thromboembolic pulmonary hypertension patients admitted in hospital.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

center of pulmonary vascular disease, Fuwai hospital

Beijing, 100037, China

RECRUITING

Chinese Academy of Medical Sciences Fuwai hospital

Beijing, 100037, China

RECRUITING

Central Study Contacts

Zhihong Liu, doctor

CONTACT

86-010-88396589zhihongliufuwai@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2019

First Posted

December 20, 2019

Study Start

May 11, 2018

Primary Completion (Estimated)

May 11, 2028

Study Completion (Estimated)

May 11, 2028

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

CN(2)