The Effect of 48 Hours GLP-1 Infusion on Left Ventricular Function, Exercise Capacity, Insulin Sensitivity and Substrate Metabolism in Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effect on global left ventricular function
研究概览
简要总结
The purpose of this study is to determine whether 48 hours of glucagon-like-peptide-1 (GLP-1) infusion can improve heart function and alter substrate metabolism in non-diabetic patients with heart failure.
详细描述
Heart failure is a major complication in patients with ischemic heart disease. It has been shown that many of these patients have areas of viable myocardium that are not effectively contributing to heart function.
Further, chronic congestive heart failure is associated with some degree of insulin resistance in both skeletal and cardiac muscle.
GLP-1 is a naturally occurring peptide hormone that acts as an incretin and has been intensively studied by many groups in association with type II diabetes and it has clearly shown its glucose lowering potential with very little risk of hypoglycemia in several trials.
Recently GLP-1 has been shown to improve cardiac function in dogs with pace-induced cardiomyopathy, and in an open-labeled study it did improve cardiac function in patients with acute myocardial infarctions.
Comparison: 48 hours of treatment with intravenous GLP-1 compared to placebo. Effect on global and regional left ventricular function, exercise capacity, insulin sensitivity and substrate metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Chronic congestive heart failure
- •Ischemic heart disease
排除标准
- •Exercise limiting disease other than heart failure
- •Congenital heart disease
- •Arterio-venous shunts
- •Renal failure
- •Valvular heart disease
研究组 & 干预措施
2
干预措施: placebo (Drug)
1
干预措施: GLP-1 (Drug)
结局指标
主要结局
Effect on global left ventricular function
时间窗: at baseline and after 48 hours of intervention
Effect on regional left ventricular function
时间窗: at baseline and after 48 hours of intervention
Effect on exercise capacity
时间窗: at baseline and after 48 hours of intervention
Effect on 6 minute walk test
时间窗: at baseline and after 48 hours of intervention
Effect on insulin sensitivity
时间窗: after 48 hours of intervention
Effect on substrate metabolism at whole-body level and in the fore-arm
时间窗: after 48 hours of intervention
次要结局
未报告次要终点