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临床试验/EUCTR2016-001513-25-DK
EUCTR2016-001513-25-DK进行中(未招募)1 期

Metformin in patients with chronic and acute heart failure: Pharmacokinetics and polymorphisms in genes encoding membrane metformin transporter proteins

Aarhus University Hospital0 个研究点目标入组 162 人开始时间: 2016年4月27日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
162

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Substudy A:
  • Patients with decompensated heart failure
  • Increased need for diuretics as judged by the clinicians
  • LVEF < 45% measured during admission or within 12 months prior to inclusion
  • NYHA-class I, II, III or IV
  • Ability to understand the written patient information and to give informed consent
  • Diabetes Type 2 (and in metformin treatment for > 1 month)
  • Stable dosage of metformin treatment for at least 1 week prior to examination
  • Substudy B:
  • Patients with heart failure
  • LVEF < 45% within 12 months prior to inclusion
  • NYHA-class I, II, III or IV
  • Ability to understand the written patient information and to give informed consent
  • Diabetes Type 2 (and in metformin treatment for > 1 month)
  • Stable dosage of metformin treatment for at least 1 week prior to examination
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 80
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 82

排除标准

  • Substudy A:
  • Severe cardiac failure, defined as
  • osystolic blood pressure continuously < 85 mmHg
  • osigns of tissue hypoperfusion (oliguria < 30 mL/h, altered level of consciousness, rapid deterioration of kidney function)
  • oNeed for intravenous inotropic support
  • Age < 18 years
  • Current abuse of alcohol or drugs
  • Adjustment or discontinuation of metformin dose during admission before examination
  • Substudy B:
  • Age < 18 years
  • Current abuse of alcohol or drugs

研究者

发起方
Aarhus University Hospital

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