The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

Fifth Affiliated Hospital, Sun Yat-Sen University

Status: Unknown

Conditions: Chronic Kidney Disease

Treatments: Drug: potassium losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT03604003

ZDWY.SNK.003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 2 patient groups

bedtime dosing ARB for hypertension

Experimental group

Description:

bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension

Treatment:

Drug: potassium losartan

bedtime dosing ARB for the prognosis

Experimental group

Description:

bedtime administration of potassium losartan has benefit for the prognosis of CKD patients

Treatment:

Drug: potassium losartan