Back to resultsBedtime Potassium Losartan on CKD With Nocturnal Hypertension Patients With Nondipping Blood Pressure Pattern
Primary Purpose
Chronic Kidney Disease Patients
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
potassium losartan
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Patients focused on measuring potassium losartan, CKD, nondipping BP pattern
Eligibility 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.
Sites / Locations
- The fifth affiliated hospital of Sun Yat-sen university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
bedtime dosing ARB for hypertension
bedtime dosing ARB for the prognosis
Arm Description
potassium losartan has benefit for the nondipping BP pattern
bedtime administration of potassium losartan has benefit for the prognosis of CKD patients
Outcomes
Primary Outcome Measures
renal events and Cardiovascular events
doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation
Secondary Outcome Measures
proteinuria
24h proteinuria >1g
renal function
eGFR<30ml/min/1.73m2
Thickness of the medial membrane of the carotid artery
cIMT >1mm
Left ventricle weight index
LVMI >115g/m2 (man) 和 >95g/m2 (woman)
Full Information
NCT ID
NCT03603938
First Posted
July 4, 2018
Last Updated
July 19, 2018
Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT03603938
Brief Title
Bedtime Potassium Losartan on CKD With Nocturnal Hypertension Patients With Nondipping Blood Pressure Pattern
Official Title
Effect of Potassium Losartan With Bedtime Dosing on Chronic Kidney Disease Patients With Nondipping Blood Pressure Pattern
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Patients
Keywords
potassium losartan, CKD, nondipping BP pattern
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bedtime dosing ARB for hypertension
Arm Type
Experimental
Arm Description
potassium losartan has benefit for the nondipping BP pattern
Arm Title
bedtime dosing ARB for the prognosis
Arm Type
Experimental
Arm Description
bedtime administration of potassium losartan has benefit for the prognosis of CKD patients
Intervention Type
Drug
Intervention Name(s)
potassium losartan
Other Intervention Name(s)
Kesiya
Intervention Description
treated with bedtime or awakening doses of potassium losartan
Primary Outcome Measure Information:
Title
renal events and Cardiovascular events
Description
doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation
Time Frame
5 years
Secondary Outcome Measure Information:
Title
proteinuria
Description
24h proteinuria >1g
Time Frame
5 years
Title
renal function
Description
eGFR<30ml/min/1.73m2
Time Frame
5 years
Title
Thickness of the medial membrane of the carotid artery
Description
cIMT >1mm
Time Frame
5 years
Title
Left ventricle weight index
Description
LVMI >115g/m2 (man) 和 >95g/m2 (woman)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Wang, Doctor
Phone
18520762959
Email
wt770716@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Zhu, Doctor
Phone
13600365603
Email
yezhu84@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoxuan Liu
Organizational Affiliation
GCP Office
Official's Role
Study Chair
Facility Information:
Facility Name
The fifth affiliated hospital of Sun Yat-sen university
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoxuan Liu
Phone
0756-2528188
Email
zdwygcp@126.com
First Name & Middle Initial & Last Name & Degree
Ye Ming
Phone
0756-2528188
Email
zdwygcp@126.com
First Name & Middle Initial & Last Name & Degree
Cheng Wang, Doctor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Bedtime Potassium Losartan on CKD With Nocturnal Hypertension Patients With Nondipping Blood Pressure Pattern
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