At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pulmonary endarterectomy (procedure), Balloon pulmonary angioplasty (procedure)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Pulmonary endarterectomy — procedure: Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass. · Balloon pulmonary angioplasty — procedure: Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the University of Aarhus, looks at two treatments for chronic thromboembolic pulmonary hypertension (a type of high blood pressure in the lungs caused by old blood clots): balloon pulmonary angioplasty (a procedure that uses a small balloon to open blocked lung arteries) and pulmonary endarterectomy (surgery to remove clots from the lung arteries). The trial aims to compare these two approaches. More details on what the study involves are not stated — ask the trial team.
Who can take part
- You have chronic thromboembolic pulmonary hypertension diagnosed under current European guidelines
- Your medical team has decided you could be treated with either balloon pulmonary angioplasty or pulmonary endarterectomy
- You give written informed consent
- You are aged between 18 and 79
- You can understand and follow instructions and take part for the whole study
Who may not be able to
- You are expected to live less than 12 months
- You have another health problem that contributes significantly to your pulmonary hypertension
- Either procedure cannot be done within 4 months of joining the study
- Your medical team expects your pulmonary hypertension medicines to have to change between the start and the 4-month check-up
- You are pregnant or have a positive pregnancy test (if you could become pregnant)
- You have had balloon pulmonary angioplasty or pulmonary endarterectomy before
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 79 Years
- Who
- All
- Number of participants
- 139
- Started
- 2024-04-01
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for chronic thromboembolic pulmonary hypertension
- • NA - 139 participants
- • Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism
Who can take part?
- • Ages 18 Years to 79 Years
- • Diagnosed with chronic thromboembolic pulmonary hypertension
Where?
- • Cambridge - Royal Ppworth
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 79 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Written agreement to take part from the patient
- ✓Patient age \>17 and \<80 years
- ✓Able to understand and follow instructions and to participate in the entire study period
Who cannot take part
- ✗Life expectancy \<12 months
- ✗Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients...
- ✗Not possible to perform balloon lung angioplasty or lung endarterectomy within 4 months after randomization.
- ✗Evaluated at multidisciplinary team conference that changes in lung artery hypertension treatment that targets specific changes in the cancer...
- ✗Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women
See the full criteria
Where Is This Study? (1 UK site)
Royal Ppworth
Cambridge, United Kingdom
How to Get in Touch
Asger Andersen, MD, ass.prof.
Sponsor contactCONTACT
Kristina Laut Matzen, RN,PhD
Sponsor contactCONTACT