ClinicalTrials.gg
Status unknownNCT05106179Updated Nov 3, 2021

The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma

A Phase 4 interventional study of Atenolol Pill and Propranolol Pill in Spinal Tumor, Spinal Hemangioma and Beta Blocker Toxicity, sponsored by Center for Vascular Pathology, Moscow. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-11-03.

Sponsored by Center for Vascular Pathology, Moscow · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
1,000
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Spinal hemangioma is one of the most common benign vertebral tumours. Being mostly asymptomatic, it is still associated with a pain syndrome especially if encroaches into the neural canal.

This study is organised to evaluate the efficacy and safety of β-blockers drugs in adults with spinal hemangioma.

02

Conditions studied

  • Spinal Tumor
  • Spinal Hemangioma
  • Beta Blocker Toxicity

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Keywords

  • β-blockers
  • Vertebral Hemangioma
  • Efficacy
03

In context

Spinal Cord Neoplasms

105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 50 across 69 interventional studies indexed under Spinal Cord Neoplasms.

Browse Spinal Cord Neoplasms studies →

Lead sponsor

Center for Vascular Pathology, Moscow is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • vertebral hemangioma

Exclusion criteria

Exclusion Criteria:

  • symptomatic bradycardia
  • AV block
  • decompensated heart failure
  • asthma
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Active comparator
    Previously treated + Atenolol

    The investigators suppose the outcome might be compromised if patient has been previously treated, that's why it is going to be compared to the main cohort. The results are going to be analysed separately

    Drug: Atenolol Pill

  • Active comparator
    Previously treated + Propranolol

    The investigators suppose the outcome might be compromised if patient has been previously treated, that's why it is going to be compared to the main cohort. The results are going to be analysed separately

    Drug: Propranolol Pill

Interventions

  • DrugAtenolol Pill

    Atenolol is a second-generation hydrophilic β-1-selective adrenergic antagonist, which is primarily metabolised by the kidneys.

  • DrugPropranolol Pill

    Propranolol is highly lipophilic, nonselective β-blockers, which is primarily metabolised by the liver.

06

What researchers measure

Primary outcomes

  1. Reducing tumor growth

    MRI

    Time frame: 3 months

  2. Reducing tumor

    MRI

    Time frame: 6 months

  3. Life-quality

    Valid questionnaires based on the ones, approved by EuroQol Organization

    Time frame: 3 months and 6 months

07

Study locations

1 site
  • The Vascular Anomalies Center (VAC) "Hemangioma"
    Moscow, 109028, Russian Federation
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2021; primary completion for Dec 2022, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2021
First posted
Nov 3, 2021
StartEst.
Dec 2021
Primary completionEst.
Dec 2022
CompletionEst.
Dec 2023
Last update
Nov 3, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05106179
Lead sponsor
Center for Vascular Pathology, Moscow
Responsible party
Sponsor
First posted
Nov 3, 2021
Start date
Dec 2021 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Dec 2023 (estimated)
Last update
Nov 3, 2021

Study contacts

Ekaterina Listovskaia, MD
study chair · The Vascular Anomalies Center (VAC) "Hemangioma",
Dmitry Romanov, MD
study chair · The Vascular Anomalies Center (VAC) "Hemangioma"

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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