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BPA vs. PEA in CTEPH (GO-CTEPH)

Primary Purpose

Chronic Thromboembolic Pulmonary Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary endarterectomy
Balloon pulmonary angioplasty
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Thromboembolic Pulmonary Hypertension

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    BPA group

    PEA group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in pulmonary vascular resistance
    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

    Secondary Outcome Measures

    Mean pulmonary artery pressure
    Mean pulmonary artery pressure measured by right heart catheterization
    Cardiac index
    Cardiac index measured by right heart catheterization
    Mean right atrial pressure
    Right atrial pressure measured by right heart catheterization
    Six minutes walking distance
    Six minutes walking distance
    Time to clinical worsening
    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).)
    N-terminal pro B-type natriuretic peptide
    N-terminal pro B-type natriuretic peptide
    Quality of life evaluated by the "Living with pulmonary hypertension questionnaire"
    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).

    Full Information

    First Posted
    October 4, 2021
    Last Updated
    October 27, 2021
    Sponsor
    University of Aarhus
    Collaborators
    Kerckhoff Klinik, Medical University of Vienna, Papworth Hospital NHS Foundation Trust, St. Antonius Hospital, Utrecht University, KU Leuven, Amsterdam UMC, location VUmc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05110066
    Brief Title
    BPA vs. PEA in CTEPH
    Acronym
    GO-CTEPH
    Official Title
    Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    February 1, 2025 (Anticipated)
    Study Completion Date
    March 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Kerckhoff Klinik, Medical University of Vienna, Papworth Hospital NHS Foundation Trust, St. Antonius Hospital, Utrecht University, KU Leuven, Amsterdam UMC, location VUmc

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Thromboembolic Pulmonary Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    139 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BPA group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    PEA group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pulmonary endarterectomy
    Intervention Description
    Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.
    Intervention Type
    Procedure
    Intervention Name(s)
    Balloon pulmonary angioplasty
    Intervention Description
    Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.
    Primary Outcome Measure Information:
    Title
    Change in pulmonary vascular resistance
    Description
    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
    Time Frame
    4 months and 12 months
    Secondary Outcome Measure Information:
    Title
    Mean pulmonary artery pressure
    Description
    Mean pulmonary artery pressure measured by right heart catheterization
    Time Frame
    4 months and 12 months
    Title
    Cardiac index
    Description
    Cardiac index measured by right heart catheterization
    Time Frame
    4 months and 12 months
    Title
    Mean right atrial pressure
    Description
    Right atrial pressure measured by right heart catheterization
    Time Frame
    4 months and 12 months
    Title
    Six minutes walking distance
    Description
    Six minutes walking distance
    Time Frame
    4 months and 12 months
    Title
    Time to clinical worsening
    Description
    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).)
    Time Frame
    4 months and 12 months
    Title
    N-terminal pro B-type natriuretic peptide
    Description
    N-terminal pro B-type natriuretic peptide
    Time Frame
    4 months and 12 months
    Title
    Quality of life evaluated by the "Living with pulmonary hypertension questionnaire"
    Description
    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).
    Time Frame
    4 months and 12 months
    Other Pre-specified Outcome Measures:
    Title
    Peri-operative/peri-interventional complications
    Description
    Complications related to balloon pulmonary angioplasty and pulmonary endarterectomy will be recorded
    Time Frame
    30 days
    Title
    Total length of hospital stay in both groups
    Description
    Time of hospital stay will be recorded
    Time Frame
    4 month
    Title
    Median survival at 12 month
    Description
    Deaths will be recorded recorded and a median 12 month survival will be calculated.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asger Andersen, MD, ass.prof.
    Phone
    40138052
    Ext
    0045
    Email
    asger.andersen@clin.au.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristina Laut Matzen, RN,PhD
    Phone
    +4521673903
    Email
    krlaut@clin.au.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Irene Lang, MD,Prof
    Organizational Affiliation
    Medical University of Vienna
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Harm Jan Bogaard, MD, Prof.
    Organizational Affiliation
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Marion Delcroix, MD, Prof.
    Organizational Affiliation
    KU Leuven
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Marco Post, MD, Prof.
    Organizational Affiliation
    St. Antonius Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Gregely Meszaros, MD
    Organizational Affiliation
    Pulmonary Hypertension Association Europe
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Johanna Pepke-Zaba, MD, Prof.
    Organizational Affiliation
    Papworth Hospital NHS Foundation Trust
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Christoph Wiedenroth, MD
    Organizational Affiliation
    Kerckhoff Klinik
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
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    Citation
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    BPA vs. PEA in CTEPH

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