NCT05165823已完成不适用
The Significance of Sodium Balance for Blood Pressure in Patients With Essential Hypertension and the Value of Salt-blood Test in Identifying Salt Sensitive Patients With Hypertension
Regional Hospital Holstebro2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年2月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in systolic 24-hour blood pressure
研究概览
简要总结
This is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Baseline measures will be done before intervention and outcome measures after the 4 weeks.
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
- •BMI ≤ 35 kg/m2
- •Essential hypertension
- •eGFR > 15 ml/min/1,73m2
- •Albumine-to-creatinine-ratio < 500 mg/g
- •Safe anticonception if women in childbearing age.
- •Able to adhere to dietary regimen
排除标准
- •Secondary hypertension
- •Clinically significant heart failure (NYHA 3-4)
- •Clinically significant liver disease
- •Diabetes mellitus (type 1 and 2)
- •Active cancer (except skin cancer)
- •Renal transplant
- •Recent stroke, transcient ischemic attack or myocardial infarction (within 6 months)
- •Proliferative glomerulonephritis or ANCA-related disease
- •Continuous immunosuppressant treatment
- •Pregnancy or lactation
- •Alcohol abuse
- •If the investigator finds the participant unfit to complete the project
结局指标
主要结局
Change in systolic 24-hour blood pressure
时间窗: Measured before and after 4 weeks' intervention
Difference in systolic blood pressure measured before and after intervention
次要结局
未报告次要终点
研究者
Camilla Lundgreen Duus
Doctor, Ph.D.-student
Regional Hospital Holstebro
研究点 (2)
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