Effects of the TNF-alpha Inhibiton on Blood Pressure, Hemodynamic Parameters and Biomarkers in Resistant Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean blood pressure in mmHg
研究概览
简要总结
Resistant hypertension (RH) is characterized by high blood pressure (BP) in spite of concurrent use of three or more antihypertensive agents of different classes, combined at optimal doses. Currently it has been largely discussed the influence of inflammation in RH. The BP variation promotes increased expression of pro-inflammatory cytokines, such as tumor necrosis factor-alpha, interleukins 1 and 6. It was showed that treatment with TNF-α inhibitor improves BP and endothelial function, and reduces arterial stiffness in patients with rheumatoid arthritis. Recently, it was demonstrated that TNF-α levels are increased in RH subjects compared to normotensives. This study aims to assess whether the acute inhibition of TNF-α changes hemodynamic parameters, such as mean BP levels in RH.
详细描述
This crossover, double-blind study will include 12 resistant hypertensive subjects - regularly followed at the Outpatient Resistant Hypertension Clinic/UNICAMP - which will randomized assigned to (1) saline infusion followed by infliximab infusion (TNF-α inhibitor, 3 mg/kg) and (2) infliximab followed by saline, for two hours and washout of the 40-day period between both infusions. It is expected that the TNF-α inhibition regulates hemodynamic parameters, such as mean BP, cardiac Output, total peripheral resistance, which may allow a better rational approach for the RH treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the diagnosis recommended by the AHA Statment on Resistant Hypertension (2008)
- •a 6-month period clinic follow-up
- •give written informed consent form
排除标准
- •secondary Hypertension
- •pseudoresistance hypertension (poor medication adherence and white coat hypertension)
- •patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases
- •pregnant women
- •autoimmune diseases
研究组 & 干预措施
Placebo drug
Saline infusion (250mL)
干预措施: Saline (Other)
TNF-alpha inhibitor drug
Infliximab infusion (TNF-α inhibitor, 3 mg/kg, 250mL)
干预措施: Infliximab (Biological)
结局指标
主要结局
Mean blood pressure in mmHg
时间窗: 15 minutes
Mean blood pressure will be simultaneously assessed for 15 minutes in baseline, during and post the infusions
次要结局
- Cardiac hypertrophy in g/m²(Baseline and post-1 week of the infusions)
- Endothelial function in percentage(Baseline and post-1 week of the infusions)
- Arterial stiffness in m/s(Baseline and post-1 week of the infusions)
- Tumor necrosis factor-alpha in pg/mL(Baseline and post-1 week of the infusions)
- Interleukin-6(Baseline and post-1 week of the infusions)
- Interleukin-10(Baseline and post-1 week of the infusions)
研究者
Heitor Moreno Junior
Principal investigator
University of Campinas, Brazil