Liberal Use of Sodium in Ambulatory Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Changes in skin sodium content
研究概览
简要总结
This study investigates the effects of an increased sodium intake in heart failure patients with reduced ejection fraction and age-matched volunteers without heart failure.
详细描述
At the start of the study, baseline investigations are performed including assessment of vital signs (blood pressure, heart rate, pulse oxygen saturation), weight, Everest congestion score (consisting of grading of dyspnea, orthopnea, jugular venous distention, rales, edema and fatigue), echocardiography, 24h urine collection, bio-impedance measurements and blood sample analysis with plasma renin and aldosterone Subsequently, a run-in phase of 2 weeks, without intervention, will start. After this run-in period, participants will be reassessed with the same baseline investigations. In addition, a skin biopsy will be performed as well as a blood volume measurement.
In the next phase of the study, salt intake will be increased with 3 grams daily. The salt will be packed in capsules containing 1 g of sodium chloride (NaCl). Patients will be asked to take one capsule with their breakfast, lunch and dinner. Every 2 weeks a follow-up visit is planned.
After 4 weeks of increased salt intake, a new skin biopsy will be taken and a blood volume measurement will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Heart failure patients:
- •Left ventricular ejection fraction ≤40% on echocardiogram obtained at inclusion
- •Stable dose of guideline-recommended disease modifying drugs for at least 3 months.
- •Maximum daily loop diuretic dose of 40 mg furosemide equivalents with a stable dose for the last month
- •Healthy volunteers:
- •Age > 60 y
- •Normal ejection fraction (>50%) without heart failure
- •No neurohormonal blockers for hypertension
- •Normal NT-proBNP
排除标准
- •Heart failure hospitalization for congestion or myocardial infarction in past 3 months
- •Permanent atrial fibrillation
- •New York Heart Association (NYHA) class III-IV
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min
- •Signs of congestion
- •Severe right ventricular dysfunction
- •Severe valvular disease
- •Cardiothoracic anatomy not allowing satisfactory and reproducible recordings of echocardiogram
- •Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
结局指标
主要结局
Changes in skin sodium content
时间窗: 4 weeks
Changes in skin glycosaminoglycan (GAG) content
时间窗: 4 weeks
次要结局
- Changes in cardiac geometry assessed by echo(6 weeks)
- Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance)(6 weeks)
- Changes in renal venous flow pattern(6 weeks)
- Changes in blood volume assessed by radiolabeled red blood cell technique(4 weeks)
- Changes in renal sodium handling(6 weeks)
研究者
Wilfried Mullens
Principal investigator
Ziekenhuis Oost-Limburg