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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - vertebral hemangioma.

Exclusion Criteria:

  • - symptomatic bradycardia.
  • - AV block.
  • - decompensated heart failure.
- asthma

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05106179
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Center for Vascular Pathology, Moscow
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ekaterina Listovskaia, MDDmitry Romanov, MD
Principal Investigator Affiliation The Vascular Anomalies Center (VAC) "Hemangioma",The Vascular Anomalies Center (VAC) "Hemangioma"
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries Russian Federation
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spinal Tumor, Spinal Hemangioma, Beta Blocker Toxicity
Arms & Interventions

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

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

Interventions

Drug: - Atenolol Pill

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

Drug: - Propranolol Pill

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Moscow, Russian Federation

Status

Address

The Vascular Anomalies Center (VAC) "Hemangioma"

Moscow, , 109028

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