Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- Contrast-associated acute kidney injury
研究概览
简要总结
This is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.
详细描述
The RICH Trial is a prospective, multicenter, randomized clinical trial to determine the effect of remote ischemic preconditioning on contrast associated acute kidney injury, and to characterize the effect of remote ischemic preconditioning on brain natriuretic peptide, functional capacity at one month, and major adverse kidney events (persistent renal dysfunction, renal replacement therapy, and death) at three months in patients with congestive heart failure with reduced left ventricular ejection fraction undergoing coronary angiography and/or percutaneous coronary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Age 18 years
- •Diagnosis of heart failure with reduced LVEF <50%
- •Pre-procedure intravenous normal saline fluid restriction status
- •Society for Cardiovascular Angiography and Interventions (SCAI) AKI risk score (>1%)
- •Referral for coronary angiogram and/or PCI
- •Suspected stable coronary artery disease or acute coronary syndrome
排除标准
- •Inability to give informed consent
- •Unstable BP (SBP > 200 or <80 mmHg) at the time of enrolment
- •Upper limb peripheral arterial disease
- •Unavailability of at least one arm for RIPC/Sham-RIPC application
- •Kidney transplant
- •Renal disease requiring dialysis
- •Prior exposure to contrast media within 72hrs preceding coronary angiography
- •Pregnancy
结局指标
主要结局
Contrast-associated acute kidney injury
时间窗: 24 and 48 hours time points
The investigators define contrast-associated acute kidney injury as a relative increase in serum creatinine of 0.3mg/dl compared with initial creatinine at 48 hours time point after coronary angiography and/or PCI. The will obtain levels of serum creatinine at baseline, then at 24 and 48 hours time points.
次要结局
- Brain Natriuretic Peptide (BNP)(24 and 48 hours time points)
- 6 minute walk distance(1 month)
- Major adverse kidney events(3 months)