Investigating if Nocturnal Blood Pressure Patterns Are Modifiable in Children With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Percent change in nocturnal systolic blood pressure in participants administered anti-hypertensive medications at night on Ambulatory blood pressure monitor(ing) (ABPM).
研究概览
简要总结
This is a pilot, crossover trial in which the investigator will determine if retiming of one anti-hypertensive medication from morning to evening can effectuate normal blood pressure dipping patterns in children and adolescents with chronic kidney disease.
详细描述
Normally blood pressure declines by at least 10% from daytime to nighttime. In children with chronic kidney disease (CKD), often this does not happen (termed "non-dipping"). This study is a pilot, randomized cross-over trial. The main purpose of this study is to investigate whether non-dipping can be modified with retiming of anti-hypertensives in children with CKD. This is important because in adults, non-dipping has been associated with increased cardiovascular disease risk and more rapid progression of kidney disease. Thus, identification of how to modify this in children with CKD, may lead to future randomized controlled trials to evaluate whether chronotherapy improves outcomes in this population, which is at high risk for morbidity and mortality in adulthood.
The primary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal systolic blood pressure change (%) in children with CKD, hypertension and non-dipping.
The secondary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal diastolic blood pressure change (%) in children with CKD, hypertension and non-dipping. Another secondary objective is to determine if the proportion of subjects classified as having a non-dipping pattern is significantly lower on evening dosing of anti-hypertensives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female child/adolescent up to 18 years of age with CKD
- •estimated glomerular filtration rate (eGFR) of 30 to 90 ml/min/1.73 m2
- •diagnosed with hypertension and on a stable dose of anti-hypertensive medication(s) for at least 3 months
- •Non-dipping identified on ABPM
排除标准
- •history of organ transplantation, oncological disease, or dialysis
- •inability to complete 24-hour ABPM or 24-hour urine collection
- •Children less than 6 years of age will be excluded, as they often are unable to complete a successful ABPM study (≥ 40 readings, with 1 reading per hour of sleep)
- •Currently on diuretic medications.
结局指标
主要结局
Percent change in nocturnal systolic blood pressure in participants administered anti-hypertensive medications at night on Ambulatory blood pressure monitor(ing) (ABPM).
时间窗: Baseline and Month 1
Percent change in systolic nocturnal blood pressure will be calculated as : (daytime mean SBP - nighttime mean SBP)/daytime mean SBP x 100 to assess if nocturnal BP dipping can be restored.
次要结局
- Percent change in nocturnal diastolic blood pressure in participants administered anti-hypertensive medications at night on ABPM.(Baseline and Month 1)
- Change in proportion of participants with restoration of dipping while on the intervention, defined as <10% systolic or diastolic nocturnal blood pressure change(Baseline and Month 1)