Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT03604003
Status:
UNKNOWN
Last Update Posted:
2018-07-27
First Post:
2018-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD
Sponsor:
Organization:
Raw JSON
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Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.'}, {'pmid': '22386035', 'type': 'BACKGROUND', '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.'}, {'pmid': '23877587', 'type': 'BACKGROUND', '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.'}, {'pmid': '23786938', 'type': 'BACKGROUND', '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.'}, {'pmid': '26041362', 'type': 'BACKGROUND', '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.'}, {'pmid': '21175325', 'type': 'BACKGROUND', '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.'}, {'pmid': '21705406', 'type': 'BACKGROUND', '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.'}, {'pmid': '23798459', 'type': 'BACKGROUND', '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.'}, {'pmid': '20520575', 'type': 'BACKGROUND', '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."}, {'pmid': '12802026', 'type': 'BACKGROUND', '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."}, {'pmid': '24107724', 'type': 'BACKGROUND', '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.'}, {'pmid': '2899801', 'type': 'BACKGROUND', '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."}, {'pmid': '23411432', 'type': 'BACKGROUND', '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.'}, {'pmid': '28115511', 'type': 'BACKGROUND', '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.'}, {'pmid': '21079049', 'type': 'BACKGROUND', '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.'}, {'pmid': '22378470', 'type': 'BACKGROUND', '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.'}, {'pmid': '17576859', 'type': 'BACKGROUND', '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.'}, {'pmid': '14604997', 'type': 'BACKGROUND', '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.'}, {'pmid': '19047584', 'type': 'BACKGROUND', '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.'}, {'pmid': '17574691', 'type': 'BACKGROUND', '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.'}, {'pmid': '22025630', 'type': 'BACKGROUND', '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.'}, {'pmid': '26089178', 'type': 'BACKGROUND', '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.'}, {'pmid': '27792646', 'type': 'BACKGROUND', '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.'}, {'pmid': '23172931', 'type': 'BACKGROUND', '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.'}, {'pmid': '22585951', 'type': 'BACKGROUND', '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.'}, {'pmid': '25341857', 'type': 'BACKGROUND', '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.'}, {'pmid': '12088775', 'type': 'BACKGROUND', '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.'}, {'pmid': '23282124', 'type': 'BACKGROUND', '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.'}, {'pmid': '19425241', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* daytime BP \\<135/85mmHg，nighttime BP≥120/70mmHg；；\n* presence of CKD;\n* 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;\n* signed informed consent from participating patients.\n\nExclusion Criteria:\n\n* pregnancy;\n* tumor;\n* infection;\n* renal replacement;\n* history of drug or alcohol abuse;\n* night- or shift-work employment;\n* treatment with steroids or hormonal therapy;\n* acute changes in eGFR \\>30% in the past 3 months;\n* presence of acquired immunodeficiency syndrome;\n* CV disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure,and grade III or IV retinopathy);\n* intolerance to ambulatory BP monitoring (ABPM);\n* inability to communicate and comply with all of the study requirements.'}, 'identificationModule': {'nctId': 'NCT03604003', 'briefTitle': 'The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD', 'organization': {'class': 'OTHER', 'fullName': 'Fifth Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD', 'orgStudyIdInfo': {'id': 'ZDWY.SNK.003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bedtime dosing ARB for hypertension', 'description': 'bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension', 'interventionNames': ['Drug: potassium losartan']}, {'type': 'EXPERIMENTAL', 'label': 'bedtime dosing ARB for the prognosis', 'description': 'bedtime administration of potassium losartan has benefit for the prognosis of CKD patients', 'interventionNames': ['Drug: potassium losartan']}], 'interventions': [{'name': 'potassium losartan', 'type': 'DRUG', 'otherNames': ['Kesiya'], 'description': 'treated with bedtime or awakening doses of potassium losartan', 'armGroupLabels': ['bedtime dosing ARB for hypertension', 'bedtime dosing ARB for the prognosis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cheng Wang, Doctor', 'role': 'CONTACT', 'email': 'wt770716@163.com', 'phone': '18520762959'}, {'name': 'Ye Zhu, Doctor', 'role': 'CONTACT', 'email': 'yezhu84@hotmail.com', 'phone': '13600365603'}], 'overallOfficials': [{'name': 'Shaoxuan Liu', 'role': 'STUDY_CHAIR', 'affiliation': 'GCP Office'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fifth Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Nephrology Department', 'investigatorFullName': 'Cheng Wang', 'investigatorAffiliation': 'Fifth Affiliated Hospital, Sun Yat-Sen University'}}}}