Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 4
- 主要终点
- regression of left ventricular hypertrophy
研究概览
简要总结
This study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus strict volume control (by strict dietary salt restriction and persistent ultrafiltration) without using antihypertensive drugs on cardiac structure and inflammation.
详细描述
This randomised, controlled and prospective study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus persistent strict volume control without using antihypertensive drugs on cardiac structure (mainly left ventricular hypertrophy)and inflammation.
We hypothesize that better blood pressure control and regression of left ventricular mass may be reached by a policy of strict volume control consisting of strict dietary salt restriction and persistent ultrafiltration.
258 Hypertensive hemodialysis patients (BP>130/80 mmHg and/or being on antihypertensive medication) will be randomized to two arms:
Group 1: Antihypertensive medicine will be stopped and strict volume control policy will be applied.
Group 2: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18-70 years old
- •on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
- •willingness to participate in the study with a written informed consent.
排除标准
- •to be scheduled for living donor renal transplantation
- •to have serious life-limiting co-morbid situations; namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease; pregnancy or lactating
结局指标
主要结局
regression of left ventricular hypertrophy
时间窗: one year
regression of left ventricular mass
时间窗: one year
change in left ventricular end-diastolic volume
时间窗: one year
次要结局
- change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels(one year)