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临床试验/NCT06394986
NCT06394986已完成不适用

Cardio-fistular Recirculation in Patients With Chronic Heart Failure and Preserved Left Ventricle Ejection Fraction

Moscow Regional Research and Clinical Institute (MONIKI)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Change in cardio-fistular recirculation

研究概览

简要总结

This is a single-arm cohort study aimed to evaluate change of arteriovenous fistula volume blood flow / cardiac output ratio in patients with chronic heart failure (NYHA I-II classes) and with preserved ejection fraction as a result of a hemodialysis session after a "long" interdialysis interval.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • signed informed consent,
  • > 18 years
  • maintenance ("chronic") hemodialysis,
  • native arteriovenous fistula,
  • arteriovenous fistula volume blood flow ≥1 l/min,
  • arteriovenous fistula volume blood flow / cardiac output ratio < 0.3,
  • interdialysis weight gain <5% of "dry" body weight,
  • sufficient hemodialysis dose (eKt/V > 1.2),
  • chronic heart failure (NYHA I-II classes only),
  • preserved left ventricular ejection fraction (≥50%),
  • absence of arrhythmias (except first-degree atrioventricular block block),
  • absence of heart valve disease (except mitral regurgitation grade I-II),
  • absence of intradialysis hypo/hypertension
  • "long" interdialysis interval (3 days).

排除标准

  • hypo/hypertension during or after hemodialysis,
  • arrhythmias (except first-degree atrioventricular block) after hemodialysis.

结局指标

主要结局

Change in cardio-fistular recirculation

时间窗: One hour before and two hours after the hemodialysis session.

Change in arteriovenous fistula volume blood flow / cardiac output ratio

次要结局

未报告次要终点

研究者

发起方
Moscow Regional Research and Clinical Institute (MONIKI)
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alexey Zulkarnaev

Leading Researcher in Surgical Department of Kidney Transplantation

Moscow Regional Research and Clinical Institute (MONIKI)

研究点 (1)

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