Clinical trial NCT03718585: Whole Exome Sequencing in CKD Hypertension
Official title: Whole Exome Sequencing Analysis Project in Chronic Kidney Disease Patients With Nocturnal Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension;Nephropathy
Keywords: Nocturnal Hypertension
Chronic Kidney Disease
Whole Exome Sequencing
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2018-10-24
Enrollment: 4000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients

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.


Eligibility 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.

Primary outcomes:
measure: whole exome sequencing analysis
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Fifth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Nephrology Department, the Fifth Affiliated Hospital of Sun Yat-sen University
name: Cheng Wang, Director
role: PRINCIPAL_INVESTIGATOR
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