Effect of Potassium Losartan With Bedtime Dosing on Chronic Kidney Disease Patients With Nondipping Blood Pressure Pattern
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- renal events and Cardiovascular events
研究概览
简要总结
Nondipping blood pressure (BP) pattern is a potential independent risk factor for chronic kidney disease (CKD). Whether bedtime administration of potassium losartan has benefit for anti-hypertension and the prognosis of CKD patients is not clear. Patients with nondipping BP pattern or dipping BP pattern were enrolled in this study, and the patients with nondipping BP pattern were randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan.
详细描述
Patients with nondipping BP pattern or dipping BP pattern were enrolled in this study, and the patients with nondipping BP pattern were randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan. Any patients who had any antihypertension medication at bedtime would withdrawal the drugs for 2 weeks before ABPM. Patients with nondipping BP were then randomly divided into two groups and received a bedtime or awakening dose of potassium losartan. Patients with dipping BP were called the dipper group, while the patients with nondipping BP were called the awakening dose group or bedtime dose group, according to the time of drug administration.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •night BP is SBP≥120mmHg and/or DBP≥70mmHg；
- •presence of CKD;
- •estimated GFR (eGFR)<90 mL⁄ min ⁄ 1.73 m2 (using the Modification of Diet in Renal Disease Study equation) but >30 mL⁄ min ⁄1.73 m2;
- •signed informed consent from participating patients.
排除标准
- •pregnancy;
- •infection;
- •renal replacement;
- •history of drug or alcohol abuse;
- •night- or shift-work employment;
- •treatment with steroids or hormonal therapy;
- •acute changes in eGFR >30% in the past 3 months;
- •presence of acquired immunodeficiency syndrome;
- •CV disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure,and grade III or IV retinopathy);
- •intolerance to ambulatory BP monitoring (ABPM);
- •inability to communicate and comply with all of the study requirements.
研究组 & 干预措施
bedtime dosing ARB for hypertension
potassium losartan has benefit for the nondipping BP pattern
干预措施: potassium losartan (Drug)
bedtime dosing ARB for the prognosis
bedtime administration of potassium losartan has benefit for the prognosis of CKD patients
干预措施: potassium losartan (Drug)
结局指标
主要结局
renal events and Cardiovascular events
时间窗: 5 years
doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation
次要结局
- proteinuria(5 years)
- Thickness of the medial membrane of the carotid artery(5 years)
- renal function(5 years)
- Left ventricle weight index(5 years)
研究者
Cheng Wang
Director of Nephrology Department
Fifth Affiliated Hospital, Sun Yat-Sen University