The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD
NCT ID: NCT03604003
Last Updated: 2018-07-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
252 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-11-30
Study Completion Date
2023-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Chronic Kidney Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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bedtime dosing ARB for hypertension
bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension
Group Type
EXPERIMENTAL
potassium losartan
Intervention Type
DRUG
treated with bedtime or awakening doses of potassium losartan
bedtime dosing ARB for the prognosis
bedtime administration of potassium losartan has benefit for the prognosis of CKD patients
Group Type
EXPERIMENTAL
potassium losartan
Intervention Type
DRUG
treated with bedtime or awakening doses of potassium losartan
Interventions
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potassium losartan
treated with bedtime or awakening doses of potassium losartan
Intervention Type
DRUG
Other Intervention Names
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Kesiya
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
14 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
Sponsor Role
lead
Responsible Party
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Cheng Wang
Director of Nephrology Department
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Shaoxuan Liu
Role: STUDY_CHAIR
GCP Office
Central Contacts
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References
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BACKGROUND
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BACKGROUND
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BACKGROUND
Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Hypertension. 2003 Nov;42(5):1050-65. doi: 10.1161/01.HYP.0000102971.85504.7c. No abstract available.
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Hermida RC, Ayala DE, Mojon A, Fernandez JR. Bedtime dosing of antihypertensive medications reduces cardiovascular risk in CKD. J Am Soc Nephrol. 2011 Dec;22(12):2313-21. doi: 10.1681/ASN.2011040361. Epub 2011 Oct 24.
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Wang C, Deng WJ, Gong WY, Zhang J, Tang H, Peng H, Zhang QZ, Ye ZC, Lou T. High prevalence of isolated nocturnal hypertension in Chinese patients with chronic kidney disease. J Am Heart Assoc. 2015 Jun 18;4(6):e002025. doi: 10.1161/JAHA.115.002025.
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Wang C, Li Y, Zhang J, Ye Z, Zhang Q, Ma X, Peng H, Lou T. Prognostic Effect of Isolated Nocturnal Hypertension in Chinese Patients With Nondialysis Chronic Kidney Disease. J Am Heart Assoc. 2016 Oct 10;5(10):e004198. doi: 10.1161/JAHA.116.004198.
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BACKGROUND
Rahman M, Greene T, Phillips RA, Agodoa LY, Bakris GL, Charleston J, Contreras G, Gabbai F, Hiremath L, Jamerson K, Kendrick C, Kusek JW, Lash JP, Lea J, Miller ER 3rd, Rostand S, Toto R, Wang X, Wright JT Jr, Appel LJ. A trial of 2 strategies to reduce nocturnal blood pressure in blacks with chronic kidney disease. Hypertension. 2013 Jan;61(1):82-8. doi: 10.1161/HYPERTENSIONAHA.112.200477. Epub 2012 Nov 19.
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Other Identifiers
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ZDWY.SNK.003
Identifier Type: -
Identifier Source: org_study_id
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