Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 252
- 主要终点
- renal events and Cardiovascular events
研究概览
简要总结
Isolated nocturnal hypertension (INH) has been studied among the general population and hypertensive patients. However, little insight is available on the prognostic effect of INH in patients with chronic kidney disease (CKD). This study investigated the prognostic effect of INH in a cohort of Chinese patients with nondialysis CKD.
详细描述
Patients with or without isolated nocturnal hypertension will be enrolled in this study, and the patients with isolated nocturnal hypertension will be 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 isolated nocturnal hypertension will be randomly divided into two groups and received a bedtime or awakening dose of potassium losartan.
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
- Single (Participant)
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
- •daytime BP <135/85mmHg，nighttime BP≥120/70mmHg；；
- •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
bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension
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
- renal function(5 years)
- Thickness of the medial membrane of the carotid artery(5 years)
- Left ventricle weight index(5 years)
- proteinuria(5 years)
研究者
Cheng Wang
Director of Nephrology Department
Fifth Affiliated Hospital, Sun Yat-Sen University