Diastolic RV EvAluation With Millar Catheter to Investigate the Effect of Glucagon-Like Peptide-1 (GLP-1) on Right Ventricular Function During Elective Coronary Angioplasty and Stenting - DREAM GLP-1
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups.
研究概览
简要总结
The heart requires nutrients and oxygen carried in the blood to generate energy for healthy pump function. Blood is supplied via heart vessels called coronary arteries. When the arteries narrow the investigators call this coronary artery disease. Narrowing and blockage of the coronary arteries can cause chest pain (angina), breathlessness (due to a reduction in pump function) and if prolonged even irreversible muscle damage known as a heart attack. The investigators can treat patients with coronary artery disease with drugs that reduce the workload on the heart or with balloons and hollow metal tubes (stents) to open the narrowed coronary arteries and improve the blood supply. These treatments can relieve angina, improve breathlessness and avert heart muscle damage during a heart attack. A potential new mechanistic effect is emerging by modulating the type of fuel used by the heart to generate energy more efficiently has been tested in the left ventricle. This study is designed to see if mechanistic effect provides the same protection in the right ventricle. It is hoped that this may further improve heart pump function and reduce the size of a heart attack in patients with coronary artery disease.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •Able to give informed consent
- •Elective percutaneous intervention for a single vessel right coronary artery stenosis >75%
- •Normal right ventricular function
排除标准
- •Severe co-morbidity expected life (<6months)
- •Nicorandil or a GLP-1 receptor agonist or DPP-4 inhibitor use
- •Women of child bearing age
- •Myocardial infarction within the previous 3 months
- •Previous coronary artery bypass graft to the RCA
- •Significant known left to right shunt
- •Permanent pacemaker
- •Atrial fibrillation
研究组 & 干预措施
saline placebo infusion
30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention
干预措施: Right Coronary Artery Percutaneous Coronary Intervention (Procedure)
saline placebo infusion
30 minute infusion of a saline placebo Right coronary artery percutaneous coronary intervention
干预措施: saline placebo infusion (Other)
GLP-1 infusion
30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention
干预措施: Right Coronary Artery Percutaneous Coronary Intervention (Procedure)
GLP-1 infusion
30 minute infusion of GLP-1 Right coronary artery percutaneous coronary intervention
干预措施: GLP-1 Infusion (Other)
结局指标
主要结局
Improvement in RV diastolic dysfunction (Tau, dP/dt min) between control and GLP-1 groups.
时间窗: Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later)
Tau - the time constant of diastolic relaxation is a sensitive measure of ventricular function. Control Group - 15 patients are randomised to receive a placebo saline infusion. GLP-1 Group - 15 patients are randomised to receive a GLP-1 infusion. Balloon Occlusion One - is performed at the start of the procedure and is a measure of baseline ventricular function. Balloon Occlusion Two - is performed directly after a 30 minute infusion of either the saline control or GLP-1. All measurements are performed while the patient is in the catheter laboratory.
次要结局
- Improvement in RV systolic function (EF, dP/dt max), between control and GLP-1 groups.(Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later))
- Collaterals and microcirculatory differences between control and GLP-1 groups(Change betweeen Balloon Occlusion One (Baseline) and Balloon Occlusion Two (30 minutes later))