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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

Tracking Information
First Submitted Date  ICMJE July 4, 2018
First Posted Date  ICMJE July 27, 2018
Last Update Posted Date July 27, 2018
Estimated Study Start Date  ICMJE November 30, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • proteinuria [ Time Frame: 5 years ]
    24h proteinuria >1g
  • renal function [ Time Frame: 5 years ]
    eGFR<30ml/min/1.73m2
  • Thickness of the medial membrane of the carotid artery [ Time Frame: 5 years ]
    cIMT >1mm
  • Left ventricle weight index [ Time Frame: 5 years ]
    LVMI >115g/m2 (man) 和 >95g/m2 (woman)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD
Official Title  ICMJE Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE Drug: potassium losartan
treated with bedtime or awakening doses of potassium losartan
Other Name: Kesiya
Study Arms  ICMJE
  • Experimental: bedtime dosing ARB for hypertension
    bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension
    Intervention: Drug: potassium losartan
  • Experimental: bedtime dosing ARB for the prognosis
    bedtime administration of potassium losartan has benefit for the prognosis of CKD patients
    Intervention: Drug: potassium losartan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2018)
252
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cheng Wang, Doctor 18520762959 wt770716@163.com
Contact: Ye Zhu, Doctor 13600365603 yezhu84@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03604003
Other Study ID Numbers  ICMJE ZDWY.SNK.003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shaoxuan Liu GCP Office
PRS Account Fifth Affiliated Hospital, Sun Yat-Sen University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP