The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

July 19, 2018 updated by: Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University

Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: bedtime dosing ARB for the prognosis
bedtime administration of potassium losartan has benefit for the prognosis of CKD patients
Drug: potassium losartan
treated with bedtime or awakening doses of potassium losartan
Other Names:
  • Kesiya
EXPERIMENTAL: bedtime dosing ARB for hypertension
bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension
Drug: potassium losartan
treated with bedtime or awakening doses of potassium losartan
Other Names:
  • Kesiya

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal events and Cardiovascular events
Time Frame: 5 years
doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proteinuria
Time Frame: 5 years
24h proteinuria >1g
5 years
renal function
Time Frame: 5 years
eGFR<30ml/min/1.73m2
5 years
Thickness of the medial membrane of the carotid artery
Time Frame: 5 years
cIMT >1mm
5 years
Left ventricle weight index
Time Frame: 5 years
LVMI >115g/m2 (man) 和 >95g/m2 (woman)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Shaoxuan Liu, GCP office

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 30, 2018

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (ACTUAL)

July 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZDWY.SNK.003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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