Renal Atherosclerotic Revascularization Evaluation: RAVE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Dialysis
研究概览
简要总结
The RAVE study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.
详细描述
It is uncertain whether patients with renal vascular disease will have renal or mortality benefits from re-establishing renal blood flow with renal revascularization procedures. Patients will be assessed for the standard nephrology research outcomes of progression to doubling of creatinine, need for dialysis, and death, as well as other cardiovascular outcomes. The investigators will also establish whether the use of a new inexpensive, simple and available ultrasound test, the renal resistance index (RRI), can identify patients with renal vascular disease who will not benefit from renal revascularization procedures.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg despite at least 3 antihypertensive medications
- •Systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg on two antihypertensives with: a rise in creatinine > 20% after initiation of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB); the sudden onset of hypertension occurring after age 55; hypokalemia or the presence of an abdominal bruit; a history of flash pulmonary edema; or any three of: peripheral vascular disease, coronary artery disease, cerebrovascular disease, smoking, hyperlipidemia, diabetes or male gender.
排除标准
- •Serum creatinine > 220 umol/L or estimated glomerular filtration rate (GFR) by Cockroft-Gault equation < 20 ml/min
- •Patients who are unwilling or unable to give informed consent
- •Known contraindication to renal revascularization such as anaphylactic allergy to contrast dye
- •An abdominal aortic aneurysm requiring surgery
- •A single functioning kidney; a total occlusion of the renal artery or renal artery stenosis due to fibromuscular dysplasia.
- •Previous revascularization
结局指标
主要结局
Dialysis
Death
Doubling of creatinine
次要结局
未报告次要终点