Back to resultsThe Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD
Primary Purpose
Chronic Kidney Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
potassium losartan
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD, bedtime dosing, isolated nocturnal hypertension
Eligibility 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.
Sites / Locations
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
bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension
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
NCT03604003
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
NCT03604003
Brief Title
The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD
Official Title
Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2018 (Anticipated)
Primary Completion Date
June 30, 2021 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
CKD, bedtime dosing, isolated nocturnal hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
252 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bedtime dosing ARB for hypertension
Arm Type
Experimental
Arm Description
bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension
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:
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.
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17986697
Citation
Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
Results Reference
background
PubMed Identifier
22386035
Citation
Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6. Erratum In: Lancet. 2012 Aug 18;380(9842):650.
Results Reference
background
PubMed Identifier
23877587
Citation
Liu ZH. Nephrology in china. Nat Rev Nephrol. 2013 Sep;9(9):523-8. doi: 10.1038/nrneph.2013.146. Epub 2013 Jul 23.
Results Reference
background
PubMed Identifier
23786938
Citation
Zheng Y, Cai GY, Chen XM, Fu P, Chen JH, Ding XQ, Yu XQ, Lin HL, Liu J, Xie RJ, Wang LN, Ni ZH, Liu FY, Yin AP, Xing CY, Wang L, Shi W, Liu JS, He YN, Ding GH, Li WG, Wu GL, Miao LN, Chen N, Su Z, Mei CL, Zhao JY, Gu Y, Bai YK, Luo HM, Lin S, Chen MH, Gong L, Yang YB, Yang XP, Li Y, Wan JX, Wang NS, Li HY, Xi CS, Hao L, Xu Y, Fang JA, Liu BC, Li RS, Wang R, Zhang JH, Wang JQ, Lou TQ, Shao FM, Mei F, Liu ZH, Yuan WJ, Sun SR, Zhang L, Zhou CH, Chen QK, Jia SL, Gong ZF, Guan GJ, Xia T, Zhong LB; Prevalence, Awareness, and Treatment Rates in Chronic Kidney Disease Patients with Hypertension in China (PATRIOTIC) Collaborative Group. Prevalence, awareness, treatment, and control of hypertension in the non-dialysis chronic kidney disease patients. Chin Med J (Engl). 2013 Jun;126(12):2276-80.
Results Reference
background
PubMed Identifier
26041362
Citation
Wang C, Deng WJ, Gong WY, Zhang J, Zhang QZ, Ye ZC, Lou T. Nocturnal Hypertension Correlates Better With Target Organ Damage in Patients With Chronic Kidney Disease than a Nondipping Pattern. J Clin Hypertens (Greenwich). 2015 Oct;17(10):792-801. doi: 10.1111/jch.12589. Epub 2015 Jun 4.
Results Reference
background
PubMed Identifier
21175325
Citation
Luan FL, Norman SP. Intensive blood-pressure control in hypertensive chronic kidney disease. N Engl J Med. 2010 Dec 23;363(26):2564-5; author reply 2565-6. doi: 10.1056/NEJMc1011419. No abstract available.
Results Reference
background
PubMed Identifier
21705406
Citation
Hodgkinson J, Mant J, Martin U, Guo B, Hobbs FD, Deeks JJ, Heneghan C, Roberts N, McManus RJ. Relative effectiveness of clinic and home blood pressure monitoring compared with ambulatory blood pressure monitoring in diagnosis of hypertension: systematic review. BMJ. 2011 Jun 24;342:d3621. doi: 10.1136/bmj.d3621.
Results Reference
background
PubMed Identifier
23798459
Citation
Lv J, Ehteshami P, Sarnak MJ, Tighiouart H, Jun M, Ninomiya T, Foote C, Rodgers A, Zhang H, Wang H, Strippoli GF, Perkovic V. Effects of intensive blood pressure lowering on the progression of chronic kidney disease: a systematic review and meta-analysis. CMAJ. 2013 Aug 6;185(11):949-57. doi: 10.1503/cmaj.121468. Epub 2013 Jun 24.
Results Reference
background
PubMed Identifier
20520575
Citation
Fan HQ, Li Y, Thijs L, Hansen TW, Boggia J, Kikuya M, Bjorklund-Bodegard K, Richart T, Ohkubo T, Jeppesen J, Torp-Pedersen C, Dolan E, Kuznetsova T, Stolarz-Skrzypek K, Tikhonoff V, Malyutina S, Casiglia E, Nikitin Y, Lind L, Sandoya E, Kawecka-Jaszcz K, Imai Y, Ibsen H, O'Brien E, Wang J, Staessen JA; International Database on Ambulatory Blood Pressure In Relation to Cardiovascular Outcomes Investigators. Prognostic value of isolated nocturnal hypertension on ambulatory measurement in 8711 individuals from 10 populations. J Hypertens. 2010 Oct;28(10):2036-45. doi: 10.1097/HJH.0b013e32833b49fe.
Results Reference
background
PubMed Identifier
12802026
Citation
Clement DL, De Buyzere ML, De Bacquer DA, de Leeuw PW, Duprez DA, Fagard RH, Gheeraert PJ, Missault LH, Braun JJ, Six RO, Van Der Niepen P, O'Brien E; Office versus Ambulatory Pressure Study Investigators. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003 Jun 12;348(24):2407-15. doi: 10.1056/NEJMoa022273.
Results Reference
background
PubMed Identifier
24107724
Citation
ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 Practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2013 Oct;31(10):1925-38. doi: 10.1097/HJH.0b013e328364ca4c. No abstract available.
Results Reference
background
PubMed Identifier
2899801
Citation
O'Brien E, Sheridan J, O'Malley K. Dippers and non-dippers. Lancet. 1988 Aug 13;2(8607):397. doi: 10.1016/s0140-6736(88)92867-x. No abstract available.
Results Reference
background
PubMed Identifier
23411432
Citation
Iimuro S, Imai E, Watanabe T, Nitta K, Akizawa T, Matsuo S, Makino H, Ohashi Y, Hishida A; Chronic Kidney Disease Japan Cohort Study Group. Clinical correlates of ambulatory BP monitoring among patients with CKD. Clin J Am Soc Nephrol. 2013 May;8(5):721-30. doi: 10.2215/CJN.06470612. Epub 2013 Feb 14.
Results Reference
background
PubMed Identifier
28115511
Citation
Hering D. Predictive Role of Nighttime Blood Pressure in Response to Renal Denervation: Evidence From the DENER-HTN Study (Renal Denervation for Hypertension). Hypertension. 2017 Mar;69(3):398-400. doi: 10.1161/HYPERTENSIONAHA.116.08738. Epub 2017 Jan 23. No abstract available.
Results Reference
background
PubMed Identifier
21079049
Citation
Hansen TW, Li Y, Boggia J, Thijs L, Richart T, Staessen JA. Predictive role of the nighttime blood pressure. Hypertension. 2011 Jan;57(1):3-10. doi: 10.1161/HYPERTENSIONAHA.109.133900. Epub 2010 Nov 15.
Results Reference
background
PubMed Identifier
22378470
Citation
Yano Y, Kario K. Nocturnal blood pressure and cardiovascular disease: a review of recent advances. Hypertens Res. 2012 Jul;35(7):695-701. doi: 10.1038/hr.2012.26. Epub 2012 Mar 1.
Results Reference
background
PubMed Identifier
17576859
Citation
Li Y, Staessen JA, Lu L, Li LH, Wang GL, Wang JG. Is isolated nocturnal hypertension a novel clinical entity? Findings from a Chinese population study. Hypertension. 2007 Aug;50(2):333-9. doi: 10.1161/HYPERTENSIONAHA.107.087767. Epub 2007 Jun 18.
Results Reference
background
PubMed Identifier
14604997
Citation
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.
Results Reference
background
PubMed Identifier
19047584
Citation
Pogue V, Rahman M, Lipkowitz M, Toto R, Miller E, Faulkner M, Rostand S, Hiremath L, Sika M, Kendrick C, Hu B, Greene T, Appel L, Phillips RA; African American Study of Kidney Disease and Hypertension Collaborative Research Group. Disparate estimates of hypertension control from ambulatory and clinic blood pressure measurements in hypertensive kidney disease. Hypertension. 2009 Jan;53(1):20-7. doi: 10.1161/HYPERTENSIONAHA.108.115154. Epub 2008 Dec 1.
Results Reference
background
PubMed Identifier
17574691
Citation
Perez-Lloret S, Toblli JE, Cardinali DP, Malateste JC, Milei J. Nocturnal hypertension defined by fixed cut-off limits is a better predictor of left ventricular hypertrophy than non-dipping. Int J Cardiol. 2008 Jul 21;127(3):387-9. doi: 10.1016/j.ijcard.2007.04.027. Epub 2007 Jun 15.
Results Reference
background
PubMed Identifier
22025630
Citation
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.
Results Reference
background
PubMed Identifier
26089178
Citation
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.
Results Reference
background
PubMed Identifier
27792646
Citation
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.
Results Reference
background
PubMed Identifier
23172931
Citation
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.
Results Reference
background
PubMed Identifier
22585951
Citation
Verdecchia P, Angeli F, Mazzotta G, Garofoli M, Ramundo E, Gentile G, Ambrosio G, Reboldi G. Day-night dip and early-morning surge in blood pressure in hypertension: prognostic implications. Hypertension. 2012 Jul;60(1):34-42. doi: 10.1161/HYPERTENSIONAHA.112.191858. Epub 2012 May 14.
Results Reference
background
PubMed Identifier
25341857
Citation
Schillaci G, Battista F, Settimi L, Schillaci L, Pucci G. Antihypertensive drug treatment and circadian blood pressure rhythm: a review of the role of chronotherapy in hypertension. Curr Pharm Des. 2015;21(6):756-72. doi: 10.2174/1381612820666141024130013.
Results Reference
background
PubMed Identifier
12088775
Citation
Grothues F, Smith GC, Moon JC, Bellenger NG, Collins P, Klein HU, Pennell DJ. Comparison of interstudy reproducibility of cardiovascular magnetic resonance with two-dimensional echocardiography in normal subjects and in patients with heart failure or left ventricular hypertrophy. Am J Cardiol. 2002 Jul 1;90(1):29-34. doi: 10.1016/s0002-9149(02)02381-0.
Results Reference
background
PubMed Identifier
23282124
Citation
Wang C, Zhang J, Liu X, Li CC, Ye ZC, Peng H, Chen Z, Lou T. Effect of valsartan with bedtime dosing on chronic kidney disease patients with nondipping blood pressure pattern. J Clin Hypertens (Greenwich). 2013 Jan;15(1):48-54. doi: 10.1111/jch.12021. Epub 2012 Oct 9.
Results Reference
background
PubMed Identifier
19425241
Citation
Dudeja SK, Dudeja RK. Blood-pressure measurement. N Engl J Med. 2009 May 7;360(19):2034-5; author reply 2035. No abstract available.
Results Reference
background
Learn more about this trial
The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD
We'll reach out to this number within 24 hrs