Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06249802

Beta-blockade in Unruptured Intracranial Aneurysm

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital in Krakow

Krakow, Lesser Poland Voivodeship, 30-688, Poland

Location contact

Amira Bryll, MD, PhD

SUB_INVESTIGATOR

Borys M Kwinta, MD, PhD

SUB_INVESTIGATOR

Ian Perera, MD

SUB_INVESTIGATOR

Igor Szydłowski, MD

PRINCIPAL_INVESTIGATOR

Jerzy Gąsowski, MD, PhD

PRINCIPAL_INVESTIGATOR

Karolina Piotrowicz, MD, PhD

SUB_INVESTIGATOR

Kornelia M Kliś, MD, PhD

CONTACT

[email protected]

+48 12 400 2450

Kornelia M Kliś, MD, PhD

PRINCIPAL_INVESTIGATOR

Marcin P Surmiak, PhD

SUB_INVESTIGATOR

Monika Ryś, MD

SUB_INVESTIGATOR

Roger M Krzyżewski, MD, PhD

CONTACT

[email protected]

+48 12 400 2450

Roger M Krzyżewski, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • freshly (within 12 months) diagnosed unruptured intracranial aneurysm, non-eligible for surgical or endovascular treatment
  • age > 18 years
  • informed consent

Exclusion criteria

  • contraindications to β-blockers intake
  • previous SAH
  • intake of β-blocker currently or in the past
  • presence of other intracranial pathology
  • history of surgical or endovascular aneurysm treatment
  • contraindications for contrast-enhancement MRI examination

Treatment and study plan

nebivolol

Drug

12-month intake of medication

Placebo

Drug

12-month intake of matching placebo

Primary outcomes

  1. Intracranial aneurysm growth

    Time frame: 12 months

    Any increase in size of intracranial aneurysm assessed by radiology specialist based on Magnetic Resonance Angiography.

  2. Intracranial aneurysm rupture

    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).

Secondary outcomes

  1. All-cause mortality

    Time frame: 12 months

    Death of any cause

  2. Change in aneurysmal hemodynamic parameters

    Time frame: 12 months

    5% increase or decrease (relative to measurement at baseline) of one or more following parameters:

    • dome fraction very high Oscillatory Shear Index (defined as percentage of aneurysm dome with Oscillatory Shear Index higher than 0.2)
    • dome fraction of very low Wall Shear Stress (defined as percentage of aneurysm dome with Wall Shear Stress lower than 0.5)
    • Surface Vortex Fraction (defined as as percentage of flow with positive Q-criterion in small layer near aneurysm wall) All parameters will be determined based on computer modelling of blood flow in aneurysm dome.
  3. Change in aneurysm growth biomarkers

    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.

Other outcomes

  1. 5-year all-cause mortality, intracranial aneurysm rupture or necessity of neurosurgical intervention

    Time frame: 5 years

    Yearly follow-up for all-cause mortality or intracranial aneurysm rupture or neurosurgical intervention

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Collaborators

  • University Hospital in Krakow

Registry information

Acronym: BBLURAN

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

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.