The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma
Primary Purpose
Spinal Tumor, Spinal Hemangioma, Beta Blocker Toxicity
Status
Enrolling by invitation
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Atenolol Pill
Propranolol Pill
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Tumor focused on measuring β-blockers, Vertebral Hemangioma, Efficacy
Eligibility Criteria
Inclusion Criteria:
- vertebral hemangioma
Exclusion Criteria:
- symptomatic bradycardia
- AV block
- decompensated heart failure
- asthma
Sites / Locations
- The Vascular Anomalies Center (VAC) "Hemangioma"
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Previously treated + Atenolol
Previously treated + Propranolol
Arm Description
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
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
Outcomes
Primary Outcome Measures
Reducing tumor growth
MRI
Reducing tumor
MRI
Life-quality
Valid questionnaires based on the ones, approved by EuroQol Organization
Secondary Outcome Measures
Full Information
NCT ID
NCT05106179
First Posted
October 18, 2021
Last Updated
November 2, 2021
Sponsor
Center for Vascular Pathology, Moscow
1. Study Identification
Unique Protocol Identification Number
NCT05106179
Brief Title
The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma
Official Title
The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma: a Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Vascular Pathology, Moscow
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Tumor, Spinal Hemangioma, Beta Blocker Toxicity
Keywords
β-blockers, Vertebral Hemangioma, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Previously treated + Atenolol
Arm Type
Active Comparator
Arm Description
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
Arm Title
Previously treated + Propranolol
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Atenolol Pill
Intervention Description
Atenolol is a second-generation hydrophilic β-1-selective adrenergic antagonist, which is primarily metabolised by the kidneys.
Intervention Type
Drug
Intervention Name(s)
Propranolol Pill
Intervention Description
Propranolol is highly lipophilic, nonselective β-blockers, which is primarily metabolised by the liver.
Primary Outcome Measure Information:
Title
Reducing tumor growth
Description
MRI
Time Frame
3 months
Title
Reducing tumor
Description
MRI
Time Frame
6 months
Title
Life-quality
Description
Valid questionnaires based on the ones, approved by EuroQol Organization
Time Frame
3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
vertebral hemangioma
Exclusion Criteria:
symptomatic bradycardia
AV block
decompensated heart failure
asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekaterina Listovskaia, MD
Organizational Affiliation
The Vascular Anomalies Center (VAC) "Hemangioma",
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dmitry Romanov, MD
Organizational Affiliation
The Vascular Anomalies Center (VAC) "Hemangioma"
Official's Role
Study Chair
Facility Information:
Facility Name
The Vascular Anomalies Center (VAC) "Hemangioma"
City
Moscow
ZIP/Postal Code
109028
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma
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