Bedtime Potassium Losartan on CKD With Nocturnal Hypertension Patients With Nondipping Blood Pressure Pattern

Not Applicable

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

• Registration Number: NCT03603938
• Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Status Verified: 2018-06
• 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: 2018-11-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 189

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bedtime dosing ARB for hypertension	potassium losartan	potassium losartan has benefit for the nondipping BP pattern
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
Thickness of the medial membrane of the carotid artery	5 years	cIMT \>1mm
renal function	5 years	eGFR\<30ml/min/1.73m2
Left ventricle weight index	5 years	LVMI \>115g/m2 (man) 和 \>95g/m2 (woman)

Trial Locations

Locations (1)

The fifth affiliated hospital of Sun Yat-sen university; 🇨🇳 Zhuhai, Guangdong, China