Chronic Thromboembolic Pulmonary Hypertension
Conditions
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.
Interventions
PROCEDUREPulmonary endarterectomy
Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.
PROCEDUREBalloon 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.
Sponsors
Kerckhoff Klinik
Medical University of Vienna
Papworth Hospital NHS Foundation Trust
St. Antonius Hospital
Utrecht University
KU Leuven
Amsterdam UMC, location VUmc
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean right atrial pressure | 4 months and 12 months | Right atrial pressure measured by right heart catheterization |
| 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).) |
| N-terminal pro B-type natriuretic peptide | 4 months and 12 months | N-terminal pro B-type natriuretic peptide |
| 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). |
| Mean pulmonary artery pressure | 4 months and 12 months | Mean pulmonary artery pressure measured by right heart catheterization |
| Cardiac index | 4 months and 12 months | Cardiac index measured by right heart catheterization |
| Six minutes walking distance | 4 months and 12 months | Six minutes walking distance |
Other
| Measure | Time frame | Description |
|---|---|---|
| Median survival at 12 month | 12 months | Deaths will be recorded recorded and a median 12 month survival will be calculated. |
| Peri-operative/peri-interventional complications | 30 days | Complications related to balloon pulmonary angioplasty and pulmonary endarterectomy will be recorded |
| Total length of hospital stay in both groups | 4 month | Time of hospital stay will be recorded |
Countries
Denmark, United Kingdom
Contacts
Primary ContactAsger Andersen, MD, ass.prof.
Backup ContactKristina Laut Matzen, RN,PhD
Outcome results
None listed