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

NCT ID: NCT05106179

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Tumor Spinal Hemangioma Beta Blocker Toxicity

Keywords

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β-blockers Vertebral Hemangioma Efficacy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Atenolol Pill

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Propranolol Pill

Intervention Type DRUG

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

Interventions

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Atenolol Pill

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

Intervention Type DRUG

Propranolol Pill

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* vertebral hemangioma

Exclusion Criteria

* symptomatic bradycardia
* AV block
* decompensated heart failure
* asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for Vascular Pathology, Moscow

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ekaterina Listovskaia, MD

Role: STUDY_CHAIR

The Vascular Anomalies Center (VAC) "Hemangioma",

Dmitry Romanov, MD

Role: STUDY_CHAIR

The Vascular Anomalies Center (VAC) "Hemangioma"

Locations

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The Vascular Anomalies Center (VAC) "Hemangioma"

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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S_Hemangioma

Identifier Type: -

Identifier Source: org_study_id