跳至主要内容
临床试验/NCT05106179
NCT05106179Unknown4 期

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

Center for Vascular Pathology, Moscow1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
1,000
试验地点
1
主要终点
Life-quality

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • vertebral hemangioma

排除标准

  • symptomatic bradycardia
  • decompensated heart failure

研究组 & 干预措施

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

干预措施: Atenolol Pill (Drug)

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

干预措施: Propranolol Pill (Drug)

结局指标

主要结局

Life-quality

时间窗: 3 months and 6 months

Valid questionnaires based on the ones, approved by EuroQol Organization

Reducing tumor growth

时间窗: 3 months

MRI

Reducing tumor

时间窗: 6 months

MRI

次要结局

未报告次要终点

研究者

发起方
Center for Vascular Pathology, Moscow
申办方类型
Other
责任方
Sponsor

研究点 (1)

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