Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Herat Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Change in cardiac output between treament groups
研究概览
简要总结
In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion
详细描述
In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion (single dose).
The following parameters will be collected: routine clinical parameters, endothelial function, cardiac structure and function by echocardiography, non-invasively assessed cardiac output and hemodynamics, serologic and of cardiac and renal function, sympathetic and RAS activation, metabolism, anabolic hormone function, inflammation, fibrosis, oxidative stress and apoptosis.
15 patients each group in are adequate to detect a difference between groups and before vs after ghrelin administration in metabolism, anabolic function and endothelial function with a power of 90% and two-sided significance of 5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or past signs of clinical HF according to the Framingham criteria
- •NT-proBNP > 300 ng/L
排除标准
- •Inability to or unwillingness to provide informed consent,
- •Participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.
研究组 & 干预措施
Ghrelin infusion
Ghrelin infusion 30 pmol/kg/min, 0.50 ml/min during 120 minutes
干预措施: Ghrelin (Biological)
Placebo
Saline 0.50 ml/min during 120 minutes
干预措施: Placebo (Biological)
结局指标
主要结局
Change in cardiac output between treament groups
时间窗: Procedure (At the end of ghrelin administration)
Assessed by non-invasive inert gas rebreathing technique (L/min)
次要结局
- GH biomarker(Procedure (At the end of ghrelin administration))
- ghrelin biomarker(Procedure (At the end of ghrelin administration))
- Change in endothelial function between treament groups(Procedure (At the end of ghrelin administration))
- Change in cardiac function between treament groups(Procedure (At the end of ghrelin administration))
研究者
Lars Lund
Professor
Karolinska University Hospital