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Whole Exome Sequencing in CKD Hypertension (WESCH)

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ClinicalTrials.gov Identifier: NCT03718585
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment
Hypertension;Nephropathy Other: whole exome sequencing analysis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 4 Years
Official Title: Whole Exome Sequencing Analysis Project in Chronic Kidney Disease Patients With Nocturnal Hypertension
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
nocturnal group
Chronic kidney disease patients with nocturnal hypertension
Other: whole exome sequencing analysis
Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing

non-nocturnal group
Chronic kidney disease patients without nocturnal hypertension
Other: whole exome sequencing analysis
Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing

non-CKD group
patients without chronic kidney disease
Other: whole exome sequencing analysis
Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing




Primary Outcome Measures :
  1. whole exome sequencing analysis [ Time Frame: 4 years ]
    Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients
Criteria

Inclusion Criteria:

  1. Age over 14 years old and <75years.
  2. The clinical data during the hospitalization period are detailed and complete.
  3. Follow-up information is available.
  4. Ambulatory blood pressure monitoring indicates nighttime blood pressure SBP≥120mmHg and/or DBP≥70mmHg.
  5. 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.

Exclusion Criteria:

  1. pregnancy.
  2. combined tumors.
  3. There is a history of drug abuse or alcohol abuse.
  4. There are serious infections recently.
  5. Life expectancy is less than half a year.
  6. Renal replacement therapy has been performed.
  7. Acquired immunodeficiency syndrome.
  8. Those who are being treated with cortisol hormones.
  9. Those who study or work at night for a long time and have irregular rest.
  10. Those who cannot cooperate or are unable to tolerate ambulatory blood pressure monitors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718585


Contacts
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Contact: Jianting Ke, Doctor 0086 756 2528953 kjt1997@163.com

Locations
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China, Guangdong
Fifth Affiliated Hospital, Sun Yat-Sen University Recruiting
Zhuhai, Guangdong, China, 519000
Contact: Cheng Wang, Director         
Sponsors and Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Cheng Wang, Director Nephrology Department, the Fifth Affiliated Hospital of Sun Yat-sen University
Additional Information:

Publications:

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Responsible Party: Cheng Wang, Director of Nephrology, Fifth Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03718585    
Other Study ID Numbers: ZDWY.SNK.001
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University:
Nocturnal Hypertension
Chronic Kidney Disease
Whole Exome Sequencing
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases