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Hypertension;NephropathyWESCHNCT03718585

Whole Exome Sequencing in CKD Hypertension

An observational study of Hypertension;Nephropathy, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Hypertension;Nephropathy
What is being tested?
whole exome sequencing analysis
How many people
4,000 participants
Where
1 siteChina
Study dates
1 Jun 2018to Oct 2022
How long will I take part?
4 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Hospitalized patients

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Jianting Ke, Doctor contact

0086 756 2528953

kjt1997@163.com

China1 site, 1 recruiting
  • Fifth Affiliated Hospital, Sun Yat-Sen University

    Zhuhai, Guangdong, 519000

    Cheng Wang, Director

    Recruiting

Other trials in China

About this study

Official title: Whole Exome Sequencing Analysis Project in Chronic Kidney Disease Patients With Nocturnal Hypertension

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.

Being tested
whole exome sequencing analysis
Keywords
Nocturnal Hypertension, Chronic Kidney Disease, Whole Exome Sequencing
Medical subject headings
Hypertensive Nephropathy, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • whole exome sequencing analysisOther

    Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing

Study groups in NCT03718585
Study groupRoleWhat they receive
nocturnal groupChronic kidney disease patients with nocturnal hypertension
Receives: Other: whole exome sequencing analysis
non-nocturnal groupChronic kidney disease patients without nocturnal hypertension
Receives: Other: whole exome sequencing analysis
non-CKD grouppatients without chronic kidney disease
Receives: Other: whole exome sequencing analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. whole exome sequencing analysis

    Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2018
  2. Study start1 Jun 2018
  3. Primary completionOct 2021 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
4,000 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03718585
Sponsor's protocol ID
ZDWY.SNK.001
Acronym
WESCH
Status last verified
Oct 2018
First submitted
23 Oct 2018
Last updated
24 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ricardo AC, Flessner MF, Eckfeldt JH, Eggers PW, Franceschini N, Go AS, Gotman NM, Kramer HJ, Kusek JW, Loehr LR, Melamed ML, Peralta CA, Raij L, Rosas SE, Talavera GA, Lash JP. Prevalence and Correlates of CKD in Hispanics/Latinos in the United States. Clin J Am Soc Nephrol. 2015 Oct 7;10(10):1757-66. doi: 10.2215/CJN.02020215. Epub 2015 Sep 28.

    PubMed 26416946
  • 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.

    PubMed 22386035
  • Foley 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.

    PubMed 20586894
  • Wang 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.

    PubMed 27713498
  • 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.

    PubMed 19047584
  • Global 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.

    PubMed 24842598
  • 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.

    PubMed 26041362
  • 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.

    PubMed 23786938
  • 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.

    PubMed 21175325
  • 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.

    PubMed 2899801
  • 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.

    PubMed 21705406
  • Mancia 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.

    PubMed 24359485
  • 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.

    PubMed 24107724
  • Mojon 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.

    PubMed 23181690
  • 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.

    PubMed 22378470

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension;Nephropathy, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianting Ke, Doctor (0086 756 2528953, kjt1997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

whole exome sequencing analysis (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03718585, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.

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