Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 24-hour urinary sodium excretion
研究概览
简要总结
Hypertension is one of the most common chronic medical conditions. The concerned sequelae are the cardiovascular complications, especially acute myocardial infarction and stroke. In Thailand, the incidence of hypertension is increasing each year. Many clinical studies found that salt intake over the reference level (>5 g/day) would result in elevated blood pressure (BP) and long-term morbidity. Dietary salt reduction campaigns were unsuccessful, in part, due to time limitation in the clinic, lacking of awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. Salt meter is a device used to detect sodium content in daily food. It will facilitate monitoring and control of salt intake. The 24-hour urinary sodium excretion is an acceptable method to reflect the quantity of sodium intake. This study aimed to compare the efficacy of salt meter plus dietary education compared with education alone in terms of salt intake reduction, blood pressure, salt taste sensitivity, and vascular consequence.
详细描述
A randomized-controlled trial was conducted in hypertensive patients whose BP was uncontrolled (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite therapy or antihypertensive-naïve. Patients were randomized to receive salt meter to use in conjunction with dietary education (group A) or receive education only (group B), and were followed up for 8 weeks. Dietary education was provided by certified dietician without awareness of patients' allocation. The primary endpoint was change in 24-hour urinary sodium excretion. Changes in BP, salt taste sensitivity threshold, cardio-ankle vascular index (CAVI), as well as motivation to maintain low salt diet were also analyzed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean SBP 140-179 mmHg or mean DBP 90-109 mmHg (average 3 times)
- •Diagnosed of hypertension for at least 3 months
- •No adjustment of antihypertensive agents for at least 1 month
- •24h Urine sodium ≥ 90 mmol/day
- •eGFR ≥ 45 ml/min/1.73 sq.m.
排除标准
- •eGFR < 45 ml/min/1.73 sq.m.
- •UACR > 300 mg/g
- •Serum potassium > 6.0 mmol/l
- •Serum sodium < 135 mmol/l
- •Unable to collect 24-hour urine
结局指标
主要结局
24-hour urinary sodium excretion
时间窗: 8 weeks
Change in 24-hour urinary sodium excretion from baseline
次要结局
- Change in systolic and diastolic blood pressure(8 weeks)
- Change in cardio-ankle vascular index (CAVI)(8 weeks)
- Improvement in salt taste sensitivity by evaluating the salt detection or recognition thresholds(8 weeks)