Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Preserved Ejection Fraction: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
Although half of the patients with HF has normal ejection fraction or slightly altered (HF-PEF) and the prognosis differs little from those with reduced ejection fraction, the pathophysiology of HF-PEF is still poorly understood.
Sodium restriction is the most common measure of self-care oriented to HF patients for management of congestive episodes. The role of this orientation in the treatment of patients with preserved ejection fraction, however, is still unclear. The evaluation of the effects of sodium restriction on neurohormonal activation and episodes of decompensation in HF-PEF can promote a better understanding of the pathophysiological progression of this complex syndrome.
详细描述
This is a randomized, parallel trial with blinded outcome assessment. The sample will include adult patients (aged ≥18 years) with a diagnosis of HF-PEF admitted for HF decompensation. The patients will be randomized to receive a diet with sodium and fluid intake restricted to 0.8 g/day and 800 mL/day respectively (intervention group) or an unrestricted diet, with 4 g/day sodium and unlimited fluid intake (control group), and followed for 7 days or until hospital discharge. The primary outcome shall consist of weight loss at 7 days or discharge. The secondary outcome includes assessment of clinical stability, neurohormonal activation, daily perception of thirst and readmission rate at 30 days.
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 (Care Provider)
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 of both sexes
- •Age equal to or above 18 years
- •Diagnosis of heart failure whit preserved ejection fraction (LVEF> 50%)
- •Patients hospitalized for heart failure decompensation whit hospital admission within 36 hours, who agree to participate in the study by signing the informed consent.
排除标准
- •Patients who present values of endogenous creatinine clearance less than or equal to 30 ml / min;
- •Cardiogenic shock,
- •Those with survival compromised by another disease in evolution and / or difficulty adhering to treatment (dementia, cognitive impairment)
研究组 & 干预措施
Intervention
Sodium restriction (1.6g sodium daily - 4g salt) combined with 800 ml of fluid intake
干预措施: Sodium restriction (Other)
Control
Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake
结局指标
主要结局
Weight loss
时间窗: seven days or hospital discharge
次要结局
- Assessment of clinical stability(Seven days or hospital discharge)
- Daily perception of thirst(Seven days or hospital discharge)
- Neurohormonal activation(On admission and at discharge)
- Readmission rate at 30 days(Patients shall be followed for 30 days after discharge.)