Effect of A Reduction in Glomerular Filtration Rate After Nephrectomy on Arterial Stiffness (EARNEST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 463
- 试验地点
- 1
- 主要终点
- Aortic Pulse Wave Velocity (aPWV) adjusted for mean arterial pressure and heart rate
研究概览
简要总结
Studies of patients with established kidney disease, even when this is mild, appear to show that they are at high risk of heart failure, stroke and sudden cardiac death. This may be because kidney disease causes stiffening of the arteries in the body which means that the heart and brain are damaged by high blood pressure. By studying patients before and after the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for the first time in man the effect of an isolated reduction in kidney function on the structure and function of the cardiovascular system.
详细描述
HYPOTHESIS
In living kidney donors, reduction in GFR post-nephrectomy results in:
- A pressure-independent increase in aortic stiffness (aPWV)
- An increase in peripheral and central blood pressure
EXPERIMENTAL DETAILS AND DESIGN OF PROPOSED INVESTIGATION We propose a prospective, longitudinal parallel group study of 200 kidney donors and 200 controls to be recruited over two years and followed up over one year.
Subjects: The only inclusion criterion is that subjects will be scheduled for nephrectomy for the purpose of kidney donation. Subjects will be recruited from centres, chosen because of their high numbers of live donor transplants and strength in vascular research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A donor group will be recruited from all patients undergoing donor nephrectomy.
- •A contemporaneous control group will be recruited from clinics, advertisements within and outside the institutions and from any local volunteer databases.
排除标准
- •These will be the same for donors and controls. The current nationally set exclusion criteria for donors include age/glomerular filtration rate (GFR) cutoff, diabetes mellitus, any history of cardiovascular or pulmonary disease, evidence of hypertensive end-organ damage, known left ventricular dysfunction (including ejection fraction < 40%) and atrial fibrillation.
结局指标
主要结局
Aortic Pulse Wave Velocity (aPWV) adjusted for mean arterial pressure and heart rate
时间窗: 12 months
次要结局
- 24 hr Ambulatory Systolic Blood Pressure(12 months)
- Clinic blood pressure(12 months)
- Number of patients newly diagnosed with hypertension(12 months)
- Augmentation index (AIx)(12 months)
- Central blood pressure(12 months)
- N-terminal prohormone of brain natriuretic peptide (NT-proBNP)(12 months)
- Urinary albumin: creatinine ratio (ACR)(12 months)
研究者
Jonathan N. Townend
Consultant Cardiologist and Honorary Reader in Cardiology
University Hospital Birmingham NHS Foundation Trust