The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

Not Applicable

• Conditions: Chronic Kidney Disease
• Interventions: Drug: potassium losartan

• Registration Number: NCT03604003
• Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-19
• Last Update Submitted: 2018-07-19
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Study Start: 2018-11-30
• Primary Completion: 2021-06-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bedtime dosing ARB for hypertension	potassium losartan	bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension
bedtime dosing ARB for the prognosis	potassium losartan	bedtime administration of potassium losartan has benefit for the prognosis of CKD patients

Primary Outcome Measures

Name	Time	Method
renal events and Cardiovascular events	5 years	doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation

Secondary Outcome Measures

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