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临床试验/NCT02031354
NCT02031354已完成不适用

Prospective "Pre-post" Pilot Study on the Effects of Dietary Chloride Supplementation on Neurohormonal and Diuretic Function in Patients With Heart Failure

Yale University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2014年1月最近更新:
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
11
试验地点
2
主要终点
Change in plasma renin activity following lysine chloride administration

研究概览

简要总结

The purpose of this study is to determine if administration of supplemental chloride in the form of lysine chloride to patients with congestive heart failure will affect their neurohormonal profile as well as response to diuretics.

详细描述

This prospective pilot "pre-post" study was designed to determine if supplementation of sodium free chloride ion as a lysine chloride to patients with heart failure could improve parameters of neurohormonal status and diuretic responsiveness. Volunteers will receive Lysine Chloride 7 grams three times daily for three days. At baseline and then again post lysine chloride patients will undergo sampling of venous blood for determination of neurohormonal parameters in addition to formal diuretic responsiveness testing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Fluency in English
  • Heart failure requiring loop diuretic therapy
  • Loop diuretic dose ≥ 80mg/day furosemide equivalents
  • Stable volume status and diuretic requirement as assessed by treating physician

排除标准

  • Unstable heart failure
  • renal replacement therapy or an estimated GFR < 30 ml/min/1.73m2
  • Significant bladder dysfunction
  • History of hepatic failure
  • Pregnancy
  • History of hyperinsulinemia/hyperlysinuria

研究组 & 干预措施

Lysine Chloride

Experimental

干预措施: Lysine Chloride (Dietary Supplement)

结局指标

主要结局

Change in plasma renin activity following lysine chloride administration

时间窗: 3 days

Change in diuretic response following lysine chloride administration

时间窗: 3 days

Diuretic response will me evaluated by measuring volume of urine produced following diuretic administration

Change in urinary renin level following lysine chloride administration

时间窗: 3 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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