NCT01480401已完成不适用
The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- composite clinical outcomes
研究概览
简要总结
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.
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
- Double (Investigator, Outcomes Assessor)
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
- •Patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of Heart Failure (including both those with a reduced and preserved systolic function), NYHA II-IV, and willing to sign informed consent.
排除标准
- •Subjects will be excluded if they have severe hyponatremia (serum sodium <130 mmol/L)
- •Renal failure (a glomerular filtration rate < 30 mL/min)
- •Uncontrolled thyroid disorders
- •Hepatic failure
- •Implantable cardiac device (ICD or CRT) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months
- •Uncontrolled atrial fibrillation or recurrent ventricular arrhythmias
- •Malignancy, or with moderate-severe dementia.
- •Patients will be excluded if, in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.
研究组 & 干预措施
low-sodium diet
Experimental
(1500 mg daily)
干预措施: low-sodium diet (1500 mg daily) (Other)
moderate-sodium diet
No Intervention
sodium (100 mmol or 2300 mg daily; Usual Care)
结局指标
主要结局
composite clinical outcomes
时间窗: 12 months
(cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF
次要结局
- reduces natriuretic peptide levels(12 months)
- symptoms and quality of life(12 months)
研究者
研究点 (1)
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