Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Aortic Pulse Wave Velocity (PWV)
研究概览
简要总结
The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled study.
详细描述
This study will be the first to examine whether aortic stiffness is increased in elderly patients with CKD compared to their age-matched healthy controls and further examine whether ACE-I may delay the progression of aortic stiffness in elderly CKD patients. If ACE-I therapy appears beneficial in preventing or delaying arterial stiffening in elderly patients with CKD, this work has important implications for improving the overall health of this population.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 60 years
- •BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80 - IF bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)
- •CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group
排除标准
- •Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New York Heart Association (NYHA) class III or greater).
- •Serum potassium > 5.2 meq/L
- •Known allergy or hypersensitivity to ACE inhibitor or ARB
- •Female of childbearing age not practicing contraception
- •Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week washout period)
- •History of ACE-I induced angioedema
- •History of angioedema, hereditary or idiopathic
- •Persons lacking consent capacity
- •500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios
研究组 & 干预措施
Chronic Kidney Disease-ACE-I
ace inhibitor
干预措施: lisinopril (Drug)
Chronic Kidney Disease
干预措施: angiotensin converting enzyme inhibitor (Drug)
Age matched control-ACE-I
ace-inhibitor
干预措施: lisinopril (Drug)
Age matched control
Placebo
干预措施: angiotensin converting enzyme inhibitor (Drug)
结局指标
主要结局
Aortic Pulse Wave Velocity (PWV)
时间窗: up to 12 months
PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.
次要结局
- Mean Vascular Stiffness As Measured by PWV(baseline and 12 months)
- Change in Blood Pressure From Baseline to 12 Months(up to 12 months)