NCT02012179已完成3 期
The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 806
- 试验地点
- 26
- 主要终点
- Composite Clinical Outcomes
研究概览
简要总结
SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate the efficacy of a low sodium containing diet on a composite clinical outcome composed of of all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department visits. The hypothesis of this study is that patients following a low-sodium containing diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those randomized to Usual Care.
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
- Single (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 recruited if they are 18+ years or older, with confirmed diagnosis of HF (both reduced and preserved systolic function are eligible), NYHA class II-III, and willing to sign informed consent.
排除标准
- •Subjects will be excluded if:
- •Average dietary intake of <1500 mg/ day by a quantitative or semi-quantitative method
- •Serum sodium <130mmol/L
- •Renal failure (glomerular filtration rate <30 mL/min)
- •Hepatic failure
- •Uncontrolled thyroid disorder
- •Cardiac device (ICD or CRT) or revascularization procedure (PCI or CABG) in previous month or planned in next 3 months
- •Hospitalization due to cardiovascular causes in previous 1 month
- •Uncontrolled atrial fibrillation (resting heart rate >90 bpm)
- •Active malignancy
- •Moderate-severe dementia
- •Enrolled in another interventional research study
- •Patients will be excluded, if in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.
结局指标
主要结局
Composite Clinical Outcomes
时间窗: 12 months
All-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits
次要结局
- Exercise capacity(12 months)
- Quality of life (KCCQ)(12 months)
- NYHA functional class(12 months)
研究者
研究点 (26)
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