NCT02734472

Brief Summary

Essential hypertension is a complex trait which results from interaction between environmental factors and genetic factors. The aim of this study is to investigate the effects of interaction between environmental factors and genetic factors on long-term blood pressure (BP) 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 during the whole life time, and to explore the effects of many risk factors (such as salt-sensitivity, obesity et al) on long-term BP and the occurrence of hypertension, and also to analyze the relationship of different polymorphisms of sodium and potassium metabolism-related gene with BP changes and target organ damages. 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, we attempt to examine the single nucleotide polymorphisms (SNPs) of sodium and potassium metabolism-related genes, as well as the relationship between these SNPs and BP responses to dietary sodium/potassium intervention, long-term BP change, the risk of hypertension and target organ damages were analyzed. This study would enable us to further explore the etiology of essential hypertension as well as to identify new genetic markers for predicting early hypertension and target organ damage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

March 22, 2016

Last Update Submit

September 28, 2017

Conditions

Keywords

blood pressureHypertrophy, Left VentricularVascular StiffnessProteinuriaCarotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

  • blood pressure value(mmHg)

    The follow-up study of these two cohorts will last approximately 18 months (Jul 2016 to Dec 2017). 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 (4)

  • 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

Study Arms (2)

Hanzhong cohort

A total of 4623 adolescents aged 6-15 years old in Hanzhong rural areas were recruited in 1987.During the follow-up period, the information about the incidence and risk factors of hypertension will be collected.

Other: Incidence and risk factors of hypertension

Mei county 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.

Other: Incidence and risk factors of hypertension

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.

Hanzhong cohortMei county cohort

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

Related Publications (10)

  • Mu J, Zheng S, Lian Q, Liu F, Liu Z. Evolution of blood pressure from adolescents to youth in salt sensitivies: a 18-year follow-up study in Hanzhong children cohort. Nutr J. 2012 Sep 14;11:70. doi: 10.1186/1475-2891-11-70.

  • Liu F, Zheng S, Mu J, Chu C, Wang L, Wang Y, Xiao H, Wang D, Cao Y, Ren K, Liu E, Yuan Z. Common variation in with no-lysine kinase 1 (WNK1) and blood pressure responses to dietary sodium or potassium interventions- family-based association study. Circ J. 2013;77(1):169-74. doi: 10.1253/circj.cj-12-0900. Epub 2012 Oct 12.

  • Wang L, Chang MK, Yue XM, Guo YJ, Yao YN, Liu NR, Yang BB, Niu ZJ, Gao WH, Li H, Wang Y. Associations of Genetic Variations in the NR3C2 With Salt Sensitivity, Longitudinal Blood Pressure Changes, and Incidence of Hypertension in Chinese Adults. J Clin Hypertens (Greenwich). 2025 Sep;27(9):e70137. doi: 10.1111/jch.70137.

  • Zhang X, Yao S, Wang Y, Chu C, Du M, Mu J. Associations of microRNA Gene Polymorphisms With Salt Sensitivity, Longitudinal Blood Pressure Changes, and Hypertension Incidence in the Chinese Population. J Clin Hypertens (Greenwich). 2025 Feb;27(2):e70019. doi: 10.1111/jch.70019.

  • Liao YY, Wang D, Chu C, Man ZY, Wang Y, Ma Q, Chen C, Sun Y, Mu JJ. Long-term burden and increasing trends of body mass index are linked with adult hypertension through triglyceride-glucose index: A 30-year prospective cohort study. Nutr Metab Cardiovasc Dis. 2024 Sep;34(9):2134-2142. doi: 10.1016/j.numecd.2024.05.014. Epub 2024 May 18.

  • Guo T, Zheng S, Chen T, Chu C, Ren J, Sun Y, Wang Y, He M, Yan Y, Jia H, Liao Y, Cao Y, Du M, Wang D, Yuan Z, Wang D, Mu J. The association of long-term trajectories of BMI, its variability, and metabolic syndrome: a 30-year prospective cohort study. EClinicalMedicine. 2024 Feb 12;69:102486. doi: 10.1016/j.eclinm.2024.102486. eCollection 2024 Mar.

  • Niu ZJ, Yao S, Zhang X, Mu JJ, Du MF, Zou T, Chu C, Liao YY, Hu GL, Chen C, Wang D, Ma Q, Yan Y, Jia H, Wang KK, Sun Y, Yan RC, Man ZY, Ren DF, Wang L, Gao WH, Li H, Wu YX, Li CH, Gao K, Zhang J, Yang TL, Wang Y. Associations of genetic variations in NEDD4L with salt sensitivity, blood pressure changes and hypertension incidence in Chinese adults. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1381-1389. doi: 10.1111/jch.14566. Epub 2022 Aug 30.

  • Yuan Y, Mu JJ, Chu C, Zheng WL, Wang Y, Hu JW, Ma Q, Yan Y, Liao YY, Chen C. Effect of metabolically healthy obesity on the development of arterial stiffness: a prospective cohort study. Nutr Metab (Lond). 2020 Jul 2;17:50. doi: 10.1186/s12986-020-00474-8. eCollection 2020.

  • Yuan Y, Chu C, Zheng WL, Ma Q, Hu JW, Wang Y, Yan Y, Liao YY, Mu JJ. Body Mass Index Trajectories in Early Life Is Predictive of Cardiometabolic Risk. J Pediatr. 2020 Apr;219:31-37.e6. doi: 10.1016/j.jpeds.2019.12.060. Epub 2020 Feb 12.

  • Yuan Y, Hu JW, Wang Y, Wang KK, Zheng WL, Chu C, Ma Q, Yan Y, Liao YY, Mu JJ. Association between atherogenic index of plasma and subclinical renal damage over a 12-year follow-up: Hanzhong adolescent hypertension study. Eur J Clin Nutr. 2020 Feb;74(2):278-284. doi: 10.1038/s41430-019-0530-x. Epub 2019 Nov 14.

Biospecimen

Retention: SAMPLES WITH DNA

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

HypertensionHypertrophy, Left VentricularProteinuriaCarotid Artery Diseases

Interventions

Incidence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCardiomegalyHeart DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MorbidityVital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Jianjun Mu, doctor

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianjun Mu, doctor

CONTACT

Chao Chu, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 12, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

October 2, 2017

Record last verified: 2017-09

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.

Locations