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

NCT05106179 | Unknown Phase 4

• 1 other identifier: S_Hemangioma
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Tumor; Spinal Hemangioma; Beta Blocker Toxicity

Keywords

β-blockers; Vertebral Hemangioma; Efficacy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Previously treated + Atenolol

ACTIVE COMPARATOR

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

Previously treated + Propranolol

ACTIVE COMPARATOR

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

Atenolol Pill DRUG

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

Previously treated + Atenolol

Propranolol Pill DRUG

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

Previously treated + Propranolol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• vertebral hemangioma

You may not qualify if:

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

Sponsors & Collaborators

• Center for Vascular Pathology, Moscow: lead

Study Sites (1)

The Vascular Anomalies Center (VAC) "Hemangioma"

Moscow, 109028, Russia

Location

MeSH Terms

Conditions

Spinal Cord Neoplasms

Interventions

Atenolol; Propranolol

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Ekaterina Listovskaia, MD

  The Vascular Anomalies Center (VAC) "Hemangioma",

  STUDY CHAIR

• Dmitry Romanov, MD

  The Vascular Anomalies Center (VAC) "Hemangioma"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 3, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)