Bevacizumab and Endothelium Dependent Vasodilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Vasomotor response assessed by venous occlusion strain gauge plethysmography
研究概览
简要总结
The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs.
The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years old
- •Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges.
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
排除标准
- •Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- •History of or current abuse of drugs, alcohol or solvents.
- •History of malignant disease.
- •First degree relatives with a history of cancer before the age of 50
- •First degree relatives with a history of premature cardiovascular disease before the age of 50
- •Current use of medication.
- •Clinical evidence of cardiac or pulmonary disease
- •Hypertension ( systole >140mmHG, diastole >90mmHg)
- •Diabetes mellitus
- •Any clinically relevant abnormality on ECG.
- •A history of thrombosis or first degree family members with a history of recurrent thrombosis
- •Inability to understand the nature and extent of the trial and the procedures required.
- •Previous participation in a study with bevacizumab
研究组 & 干预措施
Acetylcholine
Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab
干预措施: Acetylcholine (Drug)
Acetylcholine
Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab
干预措施: Bevacizumab (Drug)
Nitroprusside
Infusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab
干预措施: Nitroprusside (Drug)
Nitroprusside
Infusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Vasomotor response assessed by venous occlusion strain gauge plethysmography
时间窗: 15 minutes
Response to infusion of bevacizumab and/or acetylcholin or nitroprusside
次要结局
未报告次要终点
研究者
G. Rongen
Prof dr. G. Rongen
Radboud University Medical Center