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The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

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ClinicalTrials.gov Identifier: NCT03604003
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: potassium losartan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
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 Name: Kesiya
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 Name: Kesiya


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. proteinuria [ Time Frame: 5 years ]
    24h proteinuria >1g

  2. renal function [ Time Frame: 5 years ]
    eGFR<30ml/min/1.73m2

  3. Thickness of the medial membrane of the carotid artery [ Time Frame: 5 years ]
    cIMT >1mm

  4. Left ventricle weight index [ Time Frame: 5 years ]
    LVMI >115g/m2 (man) 和 >95g/m2 (woman)


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604003


Contacts
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Contact: Cheng Wang, Doctor 18520762959 wt770716@163.com
Contact: Ye Zhu, Doctor 13600365603 yezhu84@hotmail.com

Sponsors and Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Chair: Shaoxuan Liu GCP Office
More Information
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Publications:

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Responsible Party: Cheng Wang, Director of Nephrology Department, Fifth Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03604003    
Other Study ID Numbers: ZDWY.SNK.003
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University:
CKD, bedtime dosing, isolated nocturnal hypertension
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
 Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action