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

NCT03603938 | Unknown

• 1 other identifier: ZDWY.SNK.002
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Patients

Keywords

potassium losartan, CKD, nondipping BP pattern

Outcome Measures

Primary Outcomes (1)

• renal events and Cardiovascular events

  doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation

  5 years

Secondary Outcomes (4)

• proteinuria

  5 years

• renal function

  5 years

• Thickness of the medial membrane of the carotid artery

  5 years

• Left ventricle weight index

  5 years

Study Arms (2)

bedtime dosing ARB for hypertension

EXPERIMENTAL

potassium losartan has benefit for the nondipping BP pattern

Drug: potassium losartan

bedtime dosing ARB for the prognosis

EXPERIMENTAL

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

Drug: potassium losartan

Interventions

potassium losartan DRUG

treated with bedtime or awakening doses of potassium losartan

Also known as: Kesiya

bedtime dosing ARB for hypertension; bedtime dosing ARB for the prognosis

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The fifth affiliated hospital of Sun Yat-sen university

Zhuhai, Guangdong, 519000, China

Location

Related Publications (29)

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MeSH Terms

Interventions

Losartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Shaoxuan Liu

  GCP Office

  STUDY CHAIR

Central Study Contacts

Cheng Wang, Doctor

CONTACT

18520762959; wt770716@163.com

Ye Zhu, Doctor

CONTACT

13600365603; yezhu84@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nephrology Department

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 27, 2018
• Study Start: November 1, 2018
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 27, 2018

Record last verified: 2018-06

Locations

CN (1)