Whole Exome Sequencing in CKD Hypertension

• Conditions: Hypertension;Nephropathy
• Interventions: Other: whole exome sequencing analysis

• Registration Number: NCT03718585
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2018-10
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Last Update Submitted: 2018-10-23
• Study First Posted: 2018-10-24
• Last Update Posted: 2018-10-24
• Primary Completion: 2021-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nocturnal group	whole exome sequencing analysis	Chronic kidney disease patients with nocturnal hypertension
non-CKD group	whole exome sequencing analysis	patients without chronic kidney disease
non-nocturnal group	whole exome sequencing analysis	Chronic kidney disease patients without nocturnal hypertension

Primary Outcome Measures

Name	Time	Method
whole exome sequencing analysis	4 years	Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing

Trial Locations

Locations (1)

Fifth Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Zhuhai, Guangdong, China