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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03603938
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

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.

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

Detailed Description:
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. Any patients who had any antihypertension medication at bedtime would withdrawal the drugs for 2 weeks before ABPM. Patients with nondipping BP were then randomly divided into two groups and received a bedtime or awakening dose of potassium losartan. Patients with dipping BP were called the dipper group, while the patients with nondipping BP were called the awakening dose group or bedtime dose group, according to the time of drug administration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Potassium Losartan With Bedtime Dosing on Chronic Kidney Disease Patients With Nondipping Blood Pressure Pattern
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 30, 2023


Arm Intervention/treatment
Experimental: bedtime dosing ARB for hypertension
potassium losartan has benefit for the nondipping BP pattern
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




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)



Information from the National Library of Medicine

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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:

  • 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.

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.

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): NCT03603938


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

Locations
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China, Guangdong
The fifth affiliated hospital of Sun Yat-sen university
Zhuhai, Guangdong, China, 519000
Contact: Shaoxuan Liu    0756-2528188    zdwygcp@126.com   
Contact: Ye Ming    0756-2528188    zdwygcp@126.com   
Principal Investigator: Cheng Wang, Doctor         
Sponsors and Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Chair: Shaoxuan Liu GCP Office
Publications of Results:
Other Publications:

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Responsible Party: Cheng Wang, Director of Nephrology Department, Fifth Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03603938    
Other Study ID Numbers: ZDWY.SNK.002
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: June 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:
potassium losartan, CKD, nondipping BP pattern
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action