| NCT ID | NCT05110066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Chronic Thromboembolic Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 139 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 139 participants in total. It began in 2024-04-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Irene Lang, MD,Prof
STUDY CHAIR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT05110066 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Chronic Thromboembolic Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05110066 currently recruiting?
Yes, NCT05110066 is actively recruiting participants. Contact the research team at asger.andersen@clin.au.dk for enrollment information.
Where is the NCT05110066 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Cambridge, United Kingdom.
Who is sponsoring the NCT05110066 clinical trial?
NCT05110066 is sponsored by University of Aarhus. The principal investigator is Irene Lang, MD,Prof at Medical University of Vienna. The trial plans to enroll 139 participants.