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GO-CTEPH: BPA vs. PEA in CTEPH

Sponsor
University of Aarhus (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05110066
Collaborator
Kerckhoff Klinik (Other), Medical University of Vienna (Other), Papworth Hospital NHS Foundation Trust (Other), St. Antonius Hospital (Other), Utrecht University (Other), KU Leuven (Other), Amsterdam UMC, location VUmc (Other)
139
Enrollment
2
Arms
62.9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pulmonary endarterectomy
  • Procedure: Balloon pulmonary angioplasty
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
139 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in pulmonary vascular resistance [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

Secondary Outcome Measures

  1. Mean pulmonary artery pressure [4 months and 12 months]

    Mean pulmonary artery pressure measured by right heart catheterization

  2. Cardiac index [4 months and 12 months]

    Cardiac index measured by right heart catheterization

  3. Mean right atrial pressure [4 months and 12 months]

    Right atrial pressure measured by right heart catheterization

  4. Six minutes walking distance [4 months and 12 months]

    Six minutes walking distance

  5. Time to clinical worsening [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).)

  6. N-terminal pro B-type natriuretic peptide [4 months and 12 months]

    N-terminal pro B-type natriuretic peptide

  7. Quality of life evaluated by the "Living with pulmonary hypertension questionnaire" [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).

Other Outcome Measures

  1. Peri-operative/peri-interventional complications [30 days]

    Complications related to balloon pulmonary angioplasty and pulmonary endarterectomy will be recorded

  2. Total length of hospital stay in both groups [4 month]

    Time of hospital stay will be recorded

  3. Median survival at 12 month [12 months]

    Deaths will be recorded recorded and a median 12 month survival will be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Study Chair: Irene Lang, MD,Prof, Medical University of Vienna
  • Study Chair: Harm Jan Bogaard, MD, Prof., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT05110066
Other Study ID Numbers:
  • 190580-0002
First Posted:
Nov 5, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension

Study Results

No Results Posted as of Nov 5, 2021