The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: potassium losartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bedtime dosing ARB for hypertension<br>bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension | 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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CKD, bedtime dosing, isolated nocturnal hypertension