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

Sponsor

Center for Vascular Pathology, Moscow (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05106179

Collaborator

(none)

1,000

Enrollment

Location

Arms

Anticipated Duration (Months)

41.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Tumor Spinal Hemangioma Beta Blocker Toxicity	Drug: Atenolol Pill Drug: Propranolol Pill	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma: a Prospective Cohort Study

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 Atenolol is a second-generation hydrophilic β-1-selective adrenergic antagonist, which is primarily metabolised by the kidneys.
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 Propranolol is highly lipophilic, nonselective β-blockers, which is primarily metabolised by the liver.

Arm

Intervention/Treatment

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

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

Active Comparator: Previously treated + Propranolol

Drug: Propranolol Pill

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

Outcome Measures

Primary Outcome Measures

Reducing tumor growth [3 months]
MRI
Reducing tumor [6 months]
MRI
Life-quality [3 months and 6 months]
Valid questionnaires based on the ones, approved by EuroQol Organization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

vertebral hemangioma

Exclusion Criteria:

symptomatic bradycardia
AV block
decompensated heart failure
asthma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Vascular Anomalies Center (VAC) "Hemangioma"	Moscow		Russian Federation	109028

Sponsors and Collaborators

Center for Vascular Pathology, Moscow

Investigators

Study Chair: Ekaterina Listovskaia, MD, The Vascular Anomalies Center (VAC) "Hemangioma",
Study Chair: Dmitry Romanov, MD, The Vascular Anomalies Center (VAC) "Hemangioma"