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临床试验/NCT06807138
NCT06807138已完成不适用

AVF Volume Blood Flow Reduction in HD Patients with Chronic Heart Failure

Moscow Regional Research and Clinical Institute (MONIKI)1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年12月20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
86
试验地点
1
主要终点
Left ventricular ejection fraction

研究概览

简要总结

Heart failure with preserved / high cardiac output is a well-known syndrome in patients with high-flow arteriovenous fistula (AVF). However, the threshold for classifying an AVF as high-flow is currently undefined. Cardio-fistular recirculation (CFR) is often used as a criterion, with values greater than 25-30% considered cardiotoxic and associated with adverse outcomes. Additionally, CFR is one of the few easily modifiable risk factors through surgical reduction of AVF volume blood flow (Qa).

The study aimed to evaluate the extent of involution of heart structural and functional changes following Qa reduction in patients with heart failure and CFR > 25%.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Signed informed consent
  • •age > 18 years
  • •Native arteriovenous fistula or vascular graft
  • •Heart failure with preserved CO (NYHA I-IV )
  • •Cardio-fistula recirculation ≥ 25%
  • •eKt/V > 1.2
  • •Absence of arrhythmias (except grade I AV block)
  • •Absence of valvular disease (except mitral regurgitation I-II)
  • •Arteriovenous fistula blood flow reduction surgery

排除标准

  • •Kidney transplantation
  • •Conversion of vascular access to central venous catheter
  • •Withdrawal of informed consent

结局指标

主要结局

Left ventricular ejection fraction

时间窗: Before and at 6 months after surgery

Estimated pulmonary artery pressure

时间窗: Before and at 6 months after surgery

E/A ratio

时间窗: Before and at 6 months after surgery

次要结局

  • NT-proBNP serum concentration(Before and at 6 months after surgery)

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

Moscow Regional Research and Clinical Institute (MONIKI)

研究点 (1)

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