Whole Exome Sequencing in CKD Hypertension (WESCH)

October 23, 2018 updated by: Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • Fifth Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Cheng Wang, Director

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
whole exome sequencing analysis
Time Frame: 4 years
Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborators

Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZDWY.SNK.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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