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
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