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Intracranial AneurysmPhase 4BBLURANNCT06249802

Beta-blockade in Unruptured Intracranial Aneurysm

A Phase 4 study testing Nebivolol in people with Intracranial Aneurysm, run by Jagiellonian University at 1 site in Poland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysm
What is being tested?
Nebivolol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 sitePoland
Study dates
1 Jan 2025to 1 Jan 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Poland1 site

  • University Hospital in Krakow

    Krakow, Lesser Poland Voivodeship, 30-688

    Kornelia M Kliś, MD, PhD, +48 12 400 2450, kornelia.klis@uj.edu.pl

    Roger M Krzyżewski, MD, PhD, +48 12 400 2450, roger.krzyzewski@uj.edu.pl

Other trials in Poland

About this study

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.

Being tested
Nebivolol, Placebo
Keywords
beta-blocker, intracranial aneurysm, rupture prevention, hemodynamic analysis, randomized clinical trial
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NebivololDrug

    12-month intake of medication

  • PlaceboDrug

    12-month intake of matching placebo

Study groups in NCT06249802
Study groupRoleWhat they receive
Nebivolol armExperimentalPatients randomly assigned to receive active treatment with escalating doses of nebivolol.
Receives: Drug: Nebivolol
Placebo armPlacebo comparatorPatients randomly assigned to receive matching placebo tablets.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial aneurysm growth

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

    Measured: 12 months

  2. Intracranial aneurysm rupture

    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).

    Measured: 12 months

Secondary outcomes (3)

  1. All-cause mortality

    Death of any cause

    Measured: 12 months

  2. Change in aneurysmal hemodynamic parameters

    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.

    Measured: 12 months

  3. Change in aneurysm growth biomarkers

    Any change in serum levels of one or more biomarkers: IL-1,IL-6, IL-15, TGF- β and MCP-1.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patient recruitment into study will be continuous during first three years of project duration. Two arms will be created - receiving nebivolol or placebo. Dosage of nebivolol will be determined based on blood pressure and heart rate. The investigators aim to enroll a total of 100 patients - 50 for β-blocker treatment arm and 50 for placebo arm. At baseline, included patients will undergo detailed clinical examination, MRI to assess aneurysm morphology and wall, as well as vascular Doppler ultrasound to provide boundary condition for computer modelling. During first 6 months of trial, monthly control visits for each patient will be established, during which they will undergo physical examination. After 6 and 12 months all examinations will be repeated. Further follow-up will then be adopted.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249802
Sponsor's protocol ID
BBLURAN-CMUJ-14062023
Acronym
BBLURAN
Status last verified
Feb 2024
First submitted
6 Jan 2024
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nebivolol in people with Intracranial Aneurysm, run by Jagiellonian University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial aneurysm growth (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06249802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.

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