Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 504
- 试验地点
- 8
- 主要终点
- Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)
研究概览
简要总结
Multi-centre open-label 1:1 randomized clinical trial in chronic heart failure patients on the effect of fluid restriction versus liberal fluid intake on quality of life.
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)
盲法说明
The members of the event adjudication committee will be blinded for treatment allocation. Moreover, the statistician who performs the primary analysis will be blinded for treatment allocation.
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
- •Diagnosis of chronic HF with NYHA class II/III according to the prevailing guidelines > 6 months prior to randomization (1)
- •Adult (age ≥ 18 years)
排除标准
- •Reversible cause of HF (thyroid disorders, severe anemia, vitamin deficiencies)
- •Hospital admission for HF within 3 months of randomization
- •Chronic HF with NYHA class IV
- •Hyponatremia at baseline (sodium <130mmol/l)
- •Changes in HF medical therapy in last 14 days prior to randomization
- •Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 at baseline
- •Scheduled cardiac surgery within 3 months of randomization
- •Recent (within 3 months) coronary intervention (PCI or CABG) or implantation of pacemaker device
- •Comorbidity for which fluid restriction is advised by a different treating physician (e.g. nephrologist)
- •Comorbidity with a life expectancy of less than 6 months
- •The treating clinician believes that participation in the domain would not be in the best interests of the patient
- •Inability to provide informed consent
研究组 & 干预措施
Fluid restriction
Patient will receive a lifestyle advice to adhere to fluid restriction of 1500cc/day for 3 months.
干预措施: Lifestyle advice for liberal fluid intake (Behavioral)
Liberal fluid intake
Patient will receive a lifestyle advice for liberal fluid intake for 3 months.
干预措施: Lifestyle advice for liberal fluid intake (Behavioral)
结局指标
主要结局
Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: 3 months
KCCQ Overall Summary Score (OSS) (scores minimum-maximum 0-100, higher scores indicate better outcome)
次要结局
- Thirst distress(3 months)
- Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)(3 months)
- Quality of life assessed with EQ-5D-5L(3 months)
- Patient reported fluid intake(6 weeks)
- Safety (Death, all-cause hospitalisations, iv loop diuretic treatment)(6 months)