Clinical trial NCT03603938: Bedtime Potassium Losartan on CKD With Nocturnal Hypertension Patients With Nondipping Blood Pressure Pattern
Official title: Effect of Potassium Losartan With Bedtime Dosing on Chronic Kidney Disease Patients With Nondipping Blood Pressure Pattern
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Patients
Keywords: potassium losartan, CKD, nondipping BP pattern
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 189
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: 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: 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.

Eligibility criteria: 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.

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:
city: Zhuhai
country: China
facility: The fifth affiliated hospital of Sun Yat-sen university
state: Guangdong
Study officials:
affiliation: GCP Office
name: Shaoxuan Liu
role: STUDY_CHAIR
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