The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

NCT03604003 | Unknown

• 1 other identifier: ZDWY.SNK.003
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease

Keywords

CKD, bedtime dosing, isolated nocturnal hypertension

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

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

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:

• 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.

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

Related Publications (29)

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MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Losartan

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: SINGLE
• Who Masked: PARTICIPANT
• 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 30, 2018
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2023
• Last Updated: July 27, 2018

Record last verified: 2018-07