Randomized Trial to Explore the Effect of Chronotherapy Versus Conventional BP Control to Correct Abnormal Circadian BP Pattern and Improve Allograft Function in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Percent drop in mean SBP at night-time compared to mean SBP in day-time
研究概览
简要总结
The purpose of this study is to identify and manage factors related to blood pressure control that impact organ function and survival in kidney transplant recipients. Loss of the circadian (relating to a 24-hour rhythm) blood pressure pattern is common in kidney transplant recipients and is associated with poor allograft kidney function. It is still unclear if restoring the normal day-night blood pressure (BP) pattern will translate into better allograft outcome. Although studies in patients with and without chronic kidney disease indicate that restoration of the normal nocturnal (night) dipping in BP is possible by changing the timing of the BP medications to cover the overnight period (chronotherapy), this has not been tested in kidney transplant patients.
详细描述
The challenge in kidney transplantation is to identify and manage factors that impact allograft function and survival. Loss of the circadian blood pressure pattern is common in kidney transplant recipients and is associated with poor allograft kidney function. Nevertheless, it is unclear if restoring the normal day-night BP pattern will translate into better allograft outcome. Although studies in patients with and without chronic kidney disease indicate that restoration of the normal nocturnal dipping in BP is possible by changing the timing of the BP medications to cover the overnight period (chronotherapy), this has not been tested in kidney transplant patients. This exploratory study is driven by the hypothesis that chronotherapy will restore the normal circadian BP pattern and will translate into better allograft function and into lower LVM 1-year from transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of a kidney transplant.
- •Age≥18 years.
- •Stable allograft function.
- •Ability to give informed consent.
排除标准
- •Multiorgan transplant recipients.
- •Kidney transplant recipients with poor allograft function.
- •Documented history of obstructive sleep apnea.
研究组 & 干预措施
Conventional Therapy
In the conventional therapy group, no medication changes other than the ones needed to achieve target awake average SBP will be undertaken. Time at which patients are taking their BP medications will be recorded.
Intensive Therapy
In the intensive therapy group, BP medications will be adjusted to both control awake average systolic BP to target and to cover the overnight period in an attempt to control nocturnal hypertension.
干预措施: Medication Adjustment (Other)
结局指标
主要结局
Percent drop in mean SBP at night-time compared to mean SBP in day-time
时间窗: 1 year
Glomerular filtration rate
时间窗: 1 year
次要结局
- Awake mean SBP(1 year)
- Presence of abnormal circadian BP pattern in recipients on steroid free and CIN free IS(1 year)
- Change in LVM(1 year)
- Urinary microalbumin excretion(4 months & 1 year)
- Long term renal function(2 years)
- Cardiovascular events (stroke, heart failure, myocardial infarction)(2 years)