The Home Blood Pressure (BP) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis
研究概览
简要总结
The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure <140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of <140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.
详细描述
The main study be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure <140 mmHg in reducing rates of intradialytic hypotension. The target systolic blood pressure of 100-140 mmHg will be achieved using an algorithm of volume management and anti-hypertensive medication adjustment every two weeks. Home blood pressure measures will be recorded throughout via a mobile health blood pressure monitor over the 10-month study.
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
- 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
- •Aged 18 years or older
- •Undergoing in-center, thrice weekly hemodialysis for treatment of end stage renal disease (ESRD)
- •Greater than 3 months since initiation of dialysis
- •No anticipated change to peritoneal dialysis or kidney transplant within 10 months
- •Life expectancy greater than 10 months
- •Hypertension (defined as mean pre-dialysis SBP > 140 mmHg over prior 2 weeks or taking BP medications)
- •Able to obtain/measure a brachial blood pressure at dialysis and at home (e.g., no left ventricular assist device, blood pressure not been taken routinely in lower extremity at dialysis unit)
- •No condition that the primary nephrologist or PIs feel precludes participation
排除标准
- •Incarcerated or institutionalized (prohibits home blood pressure measurement)
- •Participating in another intervention study that may affect blood pressure
- •Pregnant or anticipated pregnancy or breastfeeding (as this will require increase to more than three times a week dialysis and/or preclude use of some classes of blood pressure medications)
研究组 & 干预措施
Home Systolic Blood Pressure <140 mmHg
Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <140 mmHg.
干预措施: Dry weight target adjustment (Other)
Home Systolic Blood Pressure <140 mmHg
Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <140 mmHg.
干预措施: Anti-hypertensive medications (Drug)
Pre-Dialysis Systolic Blood Pressure <140 mmHg
Participants will have their blood pressure taken by an automated blood pressure device by dialysis unit staff using regular dialysis unit equipment according to usual clinical care. Pre-dialysis blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a pre-dialysis systolic blood pressure target of <140 mmHg.
干预措施: Dry weight target adjustment (Other)
Pre-Dialysis Systolic Blood Pressure <140 mmHg
Participants will have their blood pressure taken by an automated blood pressure device by dialysis unit staff using regular dialysis unit equipment according to usual clinical care. Pre-dialysis blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a pre-dialysis systolic blood pressure target of <140 mmHg.
干预措施: Anti-hypertensive medications (Drug)
Home Systolic Blood Pressure <130 mmHg
This will be an optional, exploratory 2 month study at the end of the primary 10-month trial. Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <130 mmHg.
干预措施: Dry weight target adjustment (Other)
Home Systolic Blood Pressure <130 mmHg
This will be an optional, exploratory 2 month study at the end of the primary 10-month trial. Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <130 mmHg.
干预措施: Anti-hypertensive medications (Drug)
结局指标
主要结局
Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis
时间窗: 10 months
Test the effect of treating home SBP \<140mmHg vs a pre-dialysis SBP \<140mmHg on rates of IDH
次要结局
- Fatigue by SONG-HD Score(10 months)
- Rates of hospitalizations for cardiovascular events and volume overload(10 months)
- Cramping(10 months)
- Correlation between pre-dialysis and home SBP(10 months)
研究者
Nisha Bansal
Associate Professor, Division of Nephrology
University of Washington