Longitudinal Follow-up Study in Two Chinese Hypertension Cohorts
Effect of the Interaction Between Environmental Factors and Salt-sensitive Genomics on Long-term Blood Pressure in Chinese Population
1 other identifier
observational
5,611
1 country
1
Brief Summary
Essential hypertension is a complex trait that results from interaction between environmental factors and genetic factors. Salt sensitivity is the genetic susceptibility of blood pressure to salt, and it is an intermediate genetic phenotype of essential hypertension. This study aims to investigate the effects of interaction between salt sensitivity genomics and environmental factors on long-term blood pressure (BP) and target organ damage based on two established cohorts including "the cohort of Hanzhong adolescent hypertension study" and "the cohort of Mei county adult salt-sensitive hypertension study". Firstly, the Hanzhong cohort-based follow-up study is designed to observe the track of BP from childhood, and to explore the effects of many risk factors (such as salt-sensitivity, obesity et al) on long-term BP changes and the occurrence of TODs. In addition, by using DNA samples collected from subjects of "Mei county adult salt-sensitive hypertension study" in which all participants had completed a chronic salt loading and potassium intervention trial, investigators attempt to carry out whole-exome sequencing (WES), whole-genome DNA methylation and transcriptome detection, and analyze the relationship between salt sensitivity genomics and BP responses to dietary sodium/potassium intervention, long-term BP change, the risk of target organ damages. Investigators aim to explore the role of risk factors, including salt sensitivity, in the development of hypertension, and to illustrate the effects of interaction between salt sensitivity genomics and environmental factors on hypertension and target organ damage. This study would enable the investigators to further explore the genetic mechanism of essential hypertension, to identify new genetic markers for predicting early hypertension and target organ damage as well as to provide the basis for the prevention, targeted treatment, and new drugs development of hypertension in the future.
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participants targeted
Target at P75+ for all trials
Started Sep 2021
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 31, 2021
August 1, 2021
3 months
June 21, 2020
August 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood pressure value(mmHg)
The follow-up study of these two cohorts will last approximately 24 months (Jan 2020 to Dec 2021). During this period, each subject will receive a three-day follow-up examination. Three BP (mmHg) measurements will be obtained using a mercury sphygmomanometer on the first day of the three-day follow-up period.
First day of the three-day follow-up period
Secondary Outcomes (7)
Left ventricular hypertrophy (g/m^2)
During the three-day follow-up period
Increased arterial stiffness (mm/s)
During the three-day follow-up period
Carotid artery wall thickening (mm)
During the three-day follow-up period
Microalbuminuria (mg/24h)
Second day of the three-day follow-up period
whole exome sequencing
the whole year after the follow-up period
- +2 more secondary outcomes
Study Arms (2)
Hanzhong adolescent hypertension cohort
A total of 4623 adolescents aged 6-15 years old in Hanzhong rural areas was recruited in 1987. During the follow-up period, the information about the incidence and risk factors of hypertension will be collected.
Mei county adult salt-sensitive hypertension cohort
A total of 675 individuals from 126 families were recruited in this family-based dietary intervention study. A community-based BP screening was conducted among adults aged 18-60 years in the study villages. The probands who had a mean systolic BP (SBP) between 130-160 mmHg and/or a diastolic BP (DBP) between 85-100 mmHg and no use of antihypertensive medications and their parents, siblings, spouses, and offspring were recruited in this study. During the follow-up period, the information about the incidence and risk factors of hypertension will be collected.
Interventions
During the follow-up period, General information(age, sex, BMI, blood pressure, the history of drink and smoke, medical history, etc). Blood biochemistry parameters（Lipid, hsCRP levels, etc）and other laboratory examination parameters(arterial stiffness, IMT, FMD) will be collected.
Eligibility Criteria
In March and April 1987, investigators established the cohort of Hanzhong Adolescent Hypertension Study. A total of 4,623 adolescents aged 6-15 years old in over 20 schools of three towns (Qili, Laojun and Shayan) in Hanzhong, Shaanxi, China were recruited. In 2003-2004, investigators established the cohort of Mei county adult salt-sensitive hypertension Study. This study was a family-based dietary intervention study conducted in a Han Chinese population from rural areas of northern China. A total of 675 subjects from 126 families were recruited in this cohort.
You may qualify if:
- Hanzhong cohort of Adolescent Hypertension Study:
- adolescents aged 6-15 years old in over 20 schools of three towns (Qili, Laojun and Shayan) in Hanzhong, Shaanxi, China.
- Mei county cohort of adult salt-sensitive hypertension study:
- Han individuals in rural northern China
- adults aged 18-60 years
- individuals who had a mean systolic BP (SBP) between 130-160 mmHg and/or a diastolic BP (DBP) between 85-100 mmHg and no use of antihypertensive medications were identified as the proband
- the probands'parents, siblings, spouses, and offspring were recruited for the study.
You may not qualify if:
- Secondary hypertension
- a history of severe cardiovascular disease
- chronic kidney disease or liver disease
- unable to complete the examination
- unable/refuse to sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Related Publications (2)
Zheng W, Mu J, Chu C, Hu J, Yan Y, Ma Q, Lv Y, Xu X, Wang K, Wang Y, Deng Y, Yan B, Yang R, Yang J, Ren Y, Yuan Z. Association of Blood Pressure Trajectories in Early Life with Subclinical Renal Damage in Middle Age. J Am Soc Nephrol. 2018 Dec;29(12):2835-2846. doi: 10.1681/ASN.2018030263. Epub 2018 Nov 12.
PMID: 30420422RESULTFang Y, Mu JJ, He LC, Wang SC, Liu ZQ. Salt loading on plasma asymmetrical dimethylarginine and the protective role of potassium supplement in normotensive salt-sensitive asians. Hypertension. 2006 Oct;48(4):724-9. doi: 10.1161/01.HYP.0000238159.19614.ce. Epub 2006 Sep 11.
PMID: 16966580RESULT
Biospecimen
Meixian county adult salt-sensitive hypertension study is a family-based dietary interventional study. Whole blood specimen was collected from each participant who underwent a chronic salt load and potassium supplementation trial. Genomic DNA was extracted from whole blood specimen using the GOLDMAG Whole Blood Genomic DNA Purification Kit.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianjun Mu, doctor
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2020
First Posted
July 15, 2020
Study Start
September 1, 2021
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
August 31, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
The achievements will be evaluated by papers published in specialized journals with a peer-reviewed system, and the original dates can be disclosed according to requirements.