BPA vs. PEA in CTEPH (GO-CTEPH)

April 26, 2024 updated by: University of Aarhus

Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons.

Some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

An investigator-initiated multicenter, prospective, randomized, controlled, open label, non-inferiority trial. The study will randomize (1:1) 152 patients with CTEPH who are eligible for both PEA and BPA. Patients will be screened for study inclusion at the local CTEPH multidisciplinary team conference and eligibility for both PEA and BPA will be confirmed by a central adjudication committee.

PEA or BPA will be completed within 6 months from randomization. Follow-up visit with right heart catheterization will be completed at 4 months and 12 months after PEA or last BPA session.

Primary end-point is change in pulmonary vascular resistance from baseline to 4 months and 12 months after PEA or the last BPA session.

Study Type

Interventional

Enrollment (Estimated)

139

Phase

  • Not Applicable

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 Contact Backup

  • Name: Kristina Laut Matzen, RN,PhD
  • Phone Number: +4521673903
  • Email: krlaut@clin.au.dk

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Asger Andersen, PhD
  • United Kingdom
      • Cambridge, United Kingdom
        • Recruiting
        • Royal Ppworth
        • Contact:
          • Joanna Pepke-Zaba

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 to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee
  • Written informed consent from the patient
  • Patient age >17 and <80 years
  • Able to understand and follow instructions and to participate in the entire study period

Exclusion Criteria:

  • Life expectancy <12 months
  • Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension
  • Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization.
  • Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable*
  • Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women
  • Previous balloon pulmonary angioplasty or pulmonary endarterectomy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BPA group
Balloon pulmonary angioplasty. Typically 4-8 sessions are needed to treat the patient. The specific pre-planning protocol, choice of wires and balloons, the number of vessels treated per session, and the decision that no further BPA sessions are needed is at the discretion of the treating physician.
Procedure: Balloon pulmonary angioplasty
Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.
Active Comparator: PEA group
Patients randomized to PEA will undergo surgery within 4 months after randomization and optional run-in phase. Distality of the dissection plane is at the discretion of the operating physicians.
Procedure: Pulmonary endarterectomy
Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pulmonary vascular resistance
Time Frame: 4 months and 12 months
Change in pulmonary vascular resistance from baseline to 4-months and 12-months after the procedure(s). Patients on medical treatments at baseline will remain on medical treatments until the assessment of the primary endpoint, and be taken off if hemodynamics permit
4 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean pulmonary artery pressure
Time Frame: 4 months and 12 months
Mean pulmonary artery pressure measured by right heart catheterization
4 months and 12 months
Cardiac index
Time Frame: 4 months and 12 months
Cardiac index measured by right heart catheterization
4 months and 12 months
Mean right atrial pressure
Time Frame: 4 months and 12 months
Right atrial pressure measured by right heart catheterization
4 months and 12 months
Six minutes walking distance
Time Frame: 4 months and 12 months
Six minutes walking distance
4 months and 12 months
Time to clinical worsening
Time Frame: 4 months and 12 months
Clinical worsening includes all-cause mortality, nonelective hospitalization for pulmonary artery hypertension, and disease progression (disease progression is defined as a reduction from baseline in the six minutes walking distance by 15% plus worsening functional class (except for patients already in Orld health organization functional class IV).)
4 months and 12 months
N-terminal pro B-type natriuretic peptide
Time Frame: 4 months and 12 months
N-terminal pro B-type natriuretic peptide
4 months and 12 months
Quality of life evaluated by the "Living with pulmonary hypertension questionnaire"
Time Frame: 4 months and 12 months
Measured by the use of Living with pulmonary hypertension questionnaire (21 questions scored 0-5. Minimum score is 0 and maximum score is 105. Low score means high quality of life and a high score means a low quality of life).
4 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-operative/peri-interventional complications
Time Frame: 30 days
Complications related to balloon pulmonary angioplasty and pulmonary endarterectomy will be recorded
30 days
Total length of hospital stay in both groups
Time Frame: 4 month
Time of hospital stay will be recorded
4 month
Median survival at 12 month
Time Frame: 12 months
Deaths will be recorded recorded and a median 12 month survival will be calculated.
12 months

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Medical University of Vienna
KU Leuven
Amsterdam UMC, location VUmc
St. Antonius Hospital
Papworth Hospital NHS Foundation Trust
Utrecht University
Kerckhoff Klinik

Investigators

  • Study Chair: Irene Lang, MD,Prof, Medical University of Vienna
  • Study Chair: Marion Delcroix, MD, Prof., KU Leuven
  • Study Chair: Marco Post, MD, Prof., St. Antonius Hospital
  • Study Chair: Gregely Meszaros, MD, Pulmonary Hypertension Association Europe
  • Study Chair: Johanna Pepke-Zaba, MD, Prof., Papworth Hospital NHS Foundation Trust
  • Study Chair: Christoph Wiedenroth, MD, Kerckhoff Klinik
  • Study Chair: Harm Jan Bogaard, MD, Prof., Amsterdam University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190580-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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