Clinical trial NCT03604003: The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD
Official title: Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: CKD, bedtime dosing, isolated nocturnal hypertension
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 252
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: renal events and Cardiovascular events
timeFrame: 5 years
Secondary outcomes:
measure: proteinuria
timeFrame: 5 years
measure: renal function
timeFrame: 5 years
measure: Thickness of the medial membrane of the carotid artery
timeFrame: 5 years
measure: Left ventricle weight index
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: GCP Office
name: Shaoxuan Liu
role: STUDY_CHAIR
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