NCT03122769已完成1 期
Cardiac Uptake of Metformin and Expression of Metformin Membrane Transporter Proteins in the Human Failing Myocardium
Henrik Wiggers2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2017年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Metformin uptake in the failing myocardium
研究概览
简要总结
The purpose of the study is to evaluate if metformin is taken up into the failing myocardium. Recent experimental and epidemiological studies have shown beneficial effects of metformin on heart failure. It is unknown whether this effect is direct or indirect.
The aim of the study is to investigate if metformin is taken up in heart failure using a novel 11C-metformin tracer and positron emission tomography (PET).
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
盲法说明
Open label
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
- 否
入选标准
- •Patients with chronic heart failure, Left Ventricular Ejection Fraction <45%
- •New York Heart Association (NYHA) class I, II, III
- •Relatively preserved renal function (eGFR > 30 ml/min)
- •Ability to understand the written patient information and to give informed consent
- •Negative p-HCG for women of childbearing potential
排除标准
- •Known allergy to metformin
- •Age < 18 years
- •Current abuse of alcohol or drugs
结局指标
主要结局
Metformin uptake in the failing myocardium
时间窗: 12 months
Cardiac uptake is evaluated through analysis of acquired PET-images.
次要结局
未报告次要终点
研究者
Henrik Wiggers
Senior consultant, associate professor, MD, PhD, DMSc
Aarhus University Hospital
研究点 (2)
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