University Hospital in Krakow
Krakow, Lesser Poland Voivodeship, 30-688, Poland
NCT Number: NCT06249802
Subarachnoid haemorrhage is a devastating type of stroke, with high mortality and morbidity rate. In approximately 85% of cases, it is caused by an intracranial aneurysm rupture. Majority of patients with diagnosed intracranial aneurysm are eligible for interventional treatment, however, some patients are managed conservatively. Currently, the only recommendations for patients with conservatively managed intracranial aneurysms, are routine imaging follow-ups and minimization of rupture risk factors. There are no medications proven to decrease risk of aneurysm rupture, that might be prescribed to such patients. In preliminary study the investigators found that patients with intracranial aneurysms who took β-blockers had significantly smaller aneurysm rupture rate and dome size, as well as more favorable hemodynamic parameters. No other antihypertensive drugs showed similar associations. Therefore, in this project the investigators aim to further analyze the impact of β-blocker intake on fate of intracranial aneurysm and find possible explanations for its protective role. The investigators aim to perform a randomised, double-blind, placebo-controlled clinical trial. One hundred patients with unruptured intracranial aneurysm, , qualified to conservative management will be enrolled. Two arms (50 patients each) will be receiving nebivolol or matching placebo. Treatment in each arm will last 12 months. The following examinations will be performed at baseline and at 6 and 12 months: clinical assessment, angio-MRI with vessel wall imaging, Doppler ultrasound to extract blood flow waveforms from Internal Carotid Artery, Vertebral Artery Middle Cerebral Artery, Anterior Cerebral Artery and Posterior Cerebral Artery, as well as blood samples. Based on the results the investigators will assess changes in aneurysm size and wall contrast enhancement. The investigators will also analyze levels of possible aneurysm growth biomarkers in peripheral blood. Additionally, the investigators will prepare three-dimensional models of the artery harbouring aneurysm and perform patient-specific computer modelling of blood flow through such artery to assess hemodynamic parameters of aneurysm dome. All obtained measurements will be compared at baseline and at 6 and 12 months. The investigators hypothesize that, in comparison to the placebo group, β-blocker therapy in patients with unruptured intracranial aneurysm will contribute to favorable changes in hemodynamic parameters of aneurysm dome, decrease wall degradation process and prevent from aneurysm growth.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Krakow, Lesser Poland Voivodeship, 30-688, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12-month intake of medication
12-month intake of matching placebo
Time frame: 12 months
Any increase in size of intracranial aneurysm assessed by radiology specialist based on Magnetic Resonance Angiography.
Time frame: 12 months
Fatal or non-fatal intracranial aneurysm rupture. Outcome will be determined based on presence of subarachnoid hemorrhage on head Computer Tomography (performed in case on any symptoms).
Time frame: 12 months
Death of any cause
Time frame: 12 months
5% increase or decrease (relative to measurement at baseline) of one or more following parameters:
Time frame: 12 months
Any change in serum levels of one or more biomarkers: IL-1,IL-6, IL-15, TGF- β and MCP-1.
Time frame: 5 years
Yearly follow-up for all-cause mortality or intracranial aneurysm rupture or neurosurgical intervention
Trial opening soon.
Get NotifiedJagiellonian University
Other
Acronym: BBLURAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07817511
Aneurysm, Brain Diseases
Paris, Île-de-France Region, France
View Trial DetailsNCT07749404
Aneurysm, Brain Diseases
Beijing, China
View Trial DetailsNCT07353736
Aneurysm, Arteriovenous Malformations
Guangzhou, Guangdong, China
View Trial DetailsNCT07339358
Aneurysm, Brain Diseases
Barcelona, Spain
View Trial Details