Bedtime Potassium Losartan on CKD With Nocturnal Hypertension Patients With Nondipping Blood Pressure Pattern

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Potassium Losartan With Bedtime Dosing on Chronic Kidney Disease Patients With Nondipping Blood Pressure Pattern

Conditions
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Chronic Kidney Disease Patients

Intervention / Treatment
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* Drug: potassium losartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: pregnancy; tumor; 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bedtime dosing ARB for hypertension<br>potassium losartan has benefit for the nondipping BP pattern | Drug: potassium losartan<br>* treated with bedtime or awakening doses of potassium losartan<br>* Other names: Kesiya;|
| Experimental: bedtime dosing ARB for the prognosis<br>bedtime administration of potassium losartan has benefit for the prognosis of CKD patients | Drug: potassium losartan<br>* treated with bedtime or awakening doses of potassium losartan<br>* Other names: Kesiya;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal events and Cardiovascular events | doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proteinuria | 24h proteinuria >1g | 5 years | 
| renal function | eGFR<30ml/min/1.73m2 | 5 years | 
| Thickness of the medial membrane of the carotid artery | cIMT >1mm | 5 years | 
| Left ventricle weight index | LVMI >115g/m2 (man) 和 >95g/m2 (woman) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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potassium losartan, CKD, nondipping BP pattern