NCT02964390

Brief Summary

Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option 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 patients disqualified from surgery or suffered from persistent CTEPH despite pulmonary endarterectomy. This is a interventional study analyzing the benefits and the risk of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, haemodynamics, biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL assessment with Short Form 36 (SF36) questionnaire was performed before the initiation therapy of BPA, and 3-6 months after last session of BPA.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

9.9 years

First QC Date

September 6, 2016

Last Update Submit

August 18, 2021

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

CTEPHballoon pulmonary angioplasty

Outcome Measures

Primary Outcomes (5)

  • Safety 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 3-6 months after last session

  • Improvement of haemodynamics caused by series of BPA.

    Measurements taken during right heart catheterization in at least 25 patients with accomplished interventional treatment of BPA. The measurements will include pulmonary artery pressure - PAP \[mmHg\].

    From initiation of BPA to 3-6 months after last session

  • Improvement of functional capacity caused by series of BPA.

    Examined using World Health Organization (WHO) functional capacity classification is evaluated by physician in every patient, on admission and follow up.

    From initiation of BPA to 3-6 months after last session.

  • Improvement of NT-proBNP caused by series of BPA.

    Baseline measurements of the concentration of NT-proBNP \[pg/ml\] in at least 25 subjects who accomplished their invasive treatment.

    From initiation of BPA to 3-6 months after last session.

  • Improvement of six minutes walk test caused by series of BPA.

    Six minutes walking test - 6MWT is performed according to European Society of Cardiology (ESC) guidelines. The baseline distance \[meters\] covered during the 6MWT will be compared to the follow up value in patients (at least 25) who accomplished their invasive treatment of BPA.

    From initiation of BPA to 3-6 months after last session.

Study Arms (1)

Balloon Pulmonary Angioplasty

EXPERIMENTAL

This arm includes patients qualified to BPA procedure. They have a baseline workup performed before the initiation of BPA treatment and had a follow up examination from 3 to 6 months after the last BPA session.

Procedure: Balloon Pulmonary Angioplasty

Interventions

Balloon Pulmonary AngioplastyPROCEDURE
Also known as: BPA
Balloon Pulmonary Angioplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with CTEPH according to ESC Guidelines
  • WHO functional capacity ≥ II
  • documented period of anticoagulation \> 6 months after the episode of Pulmonary Embolism,

You may not qualify if:

  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Health Center Otwock

Otwock, 05-400, Poland

RECRUITING

Study Officials

  • Marcin Kurzyna, MD,PhD

    European Health Center Otwock

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcin Kurzyna, MD, PhD

CONTACT

+48-22-7103052marcin.kurzyna@ecz-otwock.pl

Szymon Darocha, MD

CONTACT

+48-22-7103054szymon.darocha@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 6, 2016

First Posted

November 16, 2016

Study Start

July 1, 2013

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)