Whole Exome Sequencing in CKD Hypertension
WESCH
Whole Exome Sequencing Analysis Project in Chronic Kidney Disease Patients With Nocturnal Hypertension
1 other identifier
observational
4,000
1 country
1
Brief Summary
The prevalence of hypertension in patients with CKD in China is high but the control rate is low. Compared with the single blood pressure measurement method of the blood pressure of the office, ambulatory blood pressure monitoring (ABPM) can reflect the overall situation of 24-hour blood pressure, dynamic fluctuation degree and circadian rhythm change more completely and objectively. Studies have shown that patients with CKD with hypertension have their own uniqueness through ABPM measurement, and nocturnal hypertension is the main cause of poor blood pressure control. Further studies have shown that nocturnal hypertension is an independent and more effective prognostic indicator of death and CVD in patients with hypertension. Evidence from European and American countries suggests that in the CKD population, elevated nighttime blood pressure is more predictive of CKD progression or CVD than daytime blood pressure. Compared with countries such as Europe and the United States, there are differences in the causes, genetic background and daily behaviors of kidney disease in our population. It is urgent to investigate the predictive value of nocturnal hypertension for renal end point and CVD in CKD population in China. To this end, our study found for the first time that CKD patients generally have changes in nocturnal blood pressure patterns, and the anti-dope type blood pressure pattern is closely related to the target organ damage. Our further study found that the incidence of nocturnal hypertension in Chinese patients with CKD is more than 50%, and compared with non-dipping blood pressure, patients with nocturnal hypertension have more serious target organ damage, which is independent risk factors for all-cause death, cardiovascular death, renal events, and cardiovascular events in patients with CKD. These preliminary results suggest the role of nocturnal hypertension in the prognosis of CKD patients in China, but there are still the following questions: Is the occurrence of nocturnal hypertension in CKD patients related to certain gene expression? This project intends to perform whole-genome exon sequencing and analysis on CKD patients with nocturnal hypertension to determine the genetic mechanism of CKD patients with nocturnal hypertension. The completion of the subject will reveal the genetic characteristics of CKD patients with nocturnal hypertension, and provide a basis for the precise prevention and treatment of chronic kidney disease hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 24, 2018
October 1, 2018
3.3 years
October 23, 2018
October 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
whole exome sequencing analysis
Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing
4 years
Study Arms (3)
nocturnal group
Chronic kidney disease patients with nocturnal hypertension
non-nocturnal group
Chronic kidney disease patients without nocturnal hypertension
non-CKD group
patients without chronic kidney disease
Interventions
Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing
Eligibility Criteria
Hospitalized patients
You may qualify if:
- Age over 14 years old and \<75years.
- The clinical data during the hospitalization period are detailed and complete.
- Follow-up information is available.
- Ambulatory blood pressure monitoring indicates nighttime blood pressure SBP≥120mmHg and/or DBP≥70mmHg.
- Diagnosed as CKD according to the 2012 KDIGO guidelines, abnormalities of kidney structure or function, present for \>3 months, with implications for health, including glomerular filtration rate (GFR) normal and abnormal pathological damage, blood (abnormal electrolyte or other components caused by renal tubular dysfunction) or urine components (proteinuria: ACR ≥ 30mg / gCr; other abnormal urine components) abnormal, and imaging abnormalities; or unexplained GFR decline (\< 60 ml/min/1.73 m2); and eGFR ≥ 30 ml/min/1.73 m2.
You may not qualify if:
- pregnancy.
- combined tumors.
- There is a history of drug abuse or alcohol abuse.
- There are serious infections recently.
- Life expectancy is less than half a year.
- Renal replacement therapy has been performed.
- Acquired immunodeficiency syndrome.
- Those who are being treated with cortisol hormones.
- Those who study or work at night for a long time and have irregular rest.
- Those who cannot cooperate or are unable to tolerate ambulatory blood pressure monitors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fifth Affiliated Hospital, Sun Yat-Sen University
Zhuhai, Guangdong, 519000, China
Related Publications (25)
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PMID: 22386035BACKGROUNDFoley RN. Clinical epidemiology of cardiovascular disease in chronic kidney disease. J Ren Care. 2010 May;36 Suppl 1:4-8. doi: 10.1111/j.1755-6686.2010.00171.x.
PMID: 20586894BACKGROUNDWang C, Ye Z, Li Y, Zhang J, Zhang Q, Ma X, Peng H, Lou T. Prognostic Value of Reverse Dipper Blood Pressure Pattern in Chronic Kidney Disease Patients not Undergoing Dialysis: Prospective Cohort Study. Sci Rep. 2016 Oct 7;6:34932. doi: 10.1038/srep34932.
PMID: 27713498BACKGROUNDPogue 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: 19047584BACKGROUNDGlobal Burden of Metabolic Risk Factors for Chronic Diseases Collaboration. Cardiovascular disease, chronic kidney disease, and diabetes mortality burden of cardiometabolic risk factors from 1980 to 2010: a comparative risk assessment. Lancet Diabetes Endocrinol. 2014 Aug;2(8):634-47. doi: 10.1016/S2213-8587(14)70102-0. Epub 2014 May 16.
PMID: 24842598BACKGROUNDWang 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: 26041362BACKGROUNDZheng 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: 23786938BACKGROUNDLuan 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: 21175325BACKGROUNDO'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: 2899801BACKGROUNDHodgkinson 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: 21705406BACKGROUNDMancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force for the Management of Arterial Hypertension of the European Society of Hypertension and the European Society of Cardiology. 2013 ESH/ESC Practice Guidelines for the Management of Arterial Hypertension. Blood Press. 2014 Feb;23(1):3-16. doi: 10.3109/08037051.2014.868629. Epub 2013 Dec 20. No abstract available.
PMID: 24359485BACKGROUNDESH/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: 24107724BACKGROUNDMojon A, Ayala DE, Pineiro L, Otero A, Crespo JJ, Moya A, Boveda J, de Lis JP, Fernandez JR, Hermida RC; Hygia Project Investigators. Comparison of ambulatory blood pressure parameters of hypertensive patients with and without chronic kidney disease. Chronobiol Int. 2013 Mar;30(1-2):145-58. doi: 10.3109/07420528.2012.703083. Epub 2012 Oct 25.
PMID: 23181690BACKGROUNDYano 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: 22378470BACKGROUNDClement 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: 12802026BACKGROUNDHermida RC. Sleep-time ambulatory blood pressure as a prognostic marker of vascular and other risks and therapeutic target for prevention by hypertension chronotherapy: Rationale and design of the Hygia Project. Chronobiol Int. 2016;33(7):906-36. doi: 10.1080/07420528.2016.1181078. Epub 2016 May 24.
PMID: 27221952BACKGROUNDHermida RC, Ayala DE, Smolensky MH, Fernandez JR, Mojon A, Portaluppi F. Chronotherapy with conventional blood pressure medications improves management of hypertension and reduces cardiovascular and stroke risks. Hypertens Res. 2016 May;39(5):277-92. doi: 10.1038/hr.2015.142. Epub 2015 Dec 10.
PMID: 26657008BACKGROUNDHermida 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: 22025630BACKGROUNDHermida RC, Ayala DE, Mojon A, Fernandez JR. Decreasing sleep-time blood pressure determined by ambulatory monitoring reduces cardiovascular risk. J Am Coll Cardiol. 2011 Sep 6;58(11):1165-73. doi: 10.1016/j.jacc.2011.04.043.
PMID: 21884956BACKGROUNDHansen 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: 21079049BACKGROUNDFelicio JS, de Souza AC, Kohlmann N, Kohlmann O Jr, Ribeiro AB, Zanella MT. Nocturnal blood pressure fall as predictor of diabetic nephropathy in hypertensive patients with type 2 diabetes. Cardiovasc Diabetol. 2010 Aug 13;9:36. doi: 10.1186/1475-2840-9-36.
PMID: 20704750BACKGROUNDRedon J, Plancha E, Swift PA, Pons S, Munoz J, Martinez F. Nocturnal blood pressure and progression to end-stage renal disease or death in nondiabetic chronic kidney disease stages 3 and 4. J Hypertens. 2010 Mar;28(3):602-7. doi: 10.1097/HJH.0b013e328333fe4d.
PMID: 20150824BACKGROUNDMehta R, Drawz PE. Is nocturnal blood pressure reduction the secret to reducing the rate of progression of hypertensive chronic kidney disease? Curr Hypertens Rep. 2011 Oct;13(5):378-85. doi: 10.1007/s11906-011-0217-8.
PMID: 21710375BACKGROUNDWang C, Zhang J, Liu X, Li C, Ye Z, Peng H, Chen Z, Lou T. Reversed dipper blood-pressure pattern is closely related to severe renal and cardiovascular damage in patients with chronic kidney disease. PLoS One. 2013;8(2):e55419. doi: 10.1371/journal.pone.0055419. Epub 2013 Feb 5.
PMID: 23393577BACKGROUND
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheng Wang, Director
Nephrology Department, the Fifth Affiliated Hospital of Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 4 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Nephrology
Study Record Dates
First Submitted
October 23, 2018
First Posted
October 24, 2018
Study Start
June 1, 2018
Primary Completion
October 1, 2021
Study Completion
October 1, 2022
Last Updated
October 24, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share