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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Spinal Tumor; Spinal Hemangioma; Beta Blocker Toxicity
• Intervention / Treatment: Drug: Atenolol Pill; Drug: Propranolol Pill

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• vertebral hemangioma

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reducing tumor growth	MRI	3 months
Reducing tumor	MRI	6 months
Life-quality	Valid questionnaires based on the ones, approved by EuroQol Organization	3 months and 6 months

Collaborators and Investigators

• Sponsor: 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"

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Efficacy; β-blockers; Vertebral Hemangioma
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Neoplasms, Vascular Tissue; Bone Neoplasms; Hemangioma; Spinal Cord Neoplasms; Spinal Neoplasms; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Propranolol; Atenolol
• Other Study ID Numbers: S_Hemangioma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No