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HypertensionC-BPCSNCT02734472

Blood Pressure Follow-up Study in Two Chinese Cohorts(C-BPCS)

An observational study of Hypertension, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
Incidence and risk factors of hypertension
How many people
5,298 participants
Where
1 siteChina
Study dates
Jul 2016to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • During the follow-up period, the exclusion criteria are as follows:
  • 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

Trial locations and contacts

1 site in 1 country.

Jianjun Mu, doctor contact

0086-029-85323804

mujjun@163.com

Chao Chu, master contact

0086-029-85323800

iaacd@163.com

China1 site, 1 recruiting
  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Jianjun Mu, doctor, 0086-029-85323804, mujjun@163.com

    Chao chu, master, 0086-029-85323800, iaacd@163.com

    Recruiting

Other trials in China

About this study

Official title: Effect of the Interaction Between Environmental Factors and Genetic Predisposition on Long-term Blood Pressure in Chinese Population

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.

Read the detailed description

This study is a longitudinal cohort follow-up study. The main contents include:(1)Questionnaire design: questionnaire is designed according to the research contents and purposes. The standard questionnaires will be used to collect the general information, dietary habits, lifestyle, medical history and family history etc.(2)Anthropometric measurements: blood pressure, height, body weight,waist and hip, pulse will be acquired by medical practitioners who received professional trainings based on World Health Organization (WHO) standards, and passed relevant examinations.(3) Blood and urine samples collection: morning fasting blood, nocturia, and 24-hour urine specimen will be collected by medical staffs, and blind tubes will be set up according to 5% of the total samples. Blood biochemistries including serum total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose, creatinine and hsCRP can be measured using automatic biochemical analyzer. The sodium and potassium concentrations in the urine will be measured by flame photometry. The total sodium and potassium excretions in urine in 24h were calculated by multiplying the concentration and 24-h volume of urine. (4) Auxiliary examinations: Auxiliary examinations including carotid intima-media thickness, endothelium-dependent vasodilation (FMD), measurements of brachial-ankle pulse wave velocity (baPWV) and electrocardiographic parameters. The measurement will be done in hospitals by medical practitioners who received professional trainings and passed relevant examinations. (5) Single nucleotide polymorphisms detection: based on our previous studies, sodium and potassium metabolism-related gene polymorphisms will be detected using MassARRAY technology. (6) Data processing and statistics: we should input the data to the database, and utilize softwares such as SPSS, STATA, Haploview and FBAT to analyze. (7) Quality control: ① Questionnaire is strictly designed and amended by epidemiologist and clinical experts. ② A standardized "Investigator Handbook" will be stipulated according to the guidelines. ③ Staff members are required to do a rigorous training and pass the exam. ④ The investigation process will be strictly supervised by the principal investigator. ⑤ Data entry use the parallel double entry method. ⑥ During laboratory testing, blank control and blind detection are applied to ensure the quality. ⑦ Data analysis is performed by 2-3 postgraduates, inconsistent data need to be double checked.

Conditions
Hypertension
Being tested
Incidence and risk factors of hypertension
Keywords
blood pressure, Hypertrophy, Left Ventricular, Vascular Stiffness, Proteinuria, Carotid Artery Diseases
Medical subject headings
Hypertension, Hypertrophy, Left Ventricular, Proteinuria, Carotid Artery Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incidence and risk factors of hypertensionOther

    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.

Study groups in NCT02734472
Study groupRoleWhat they receive
Hanzhong cohortA 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.
Receives: Other: Incidence and risk factors of hypertension
Mei county cohortA 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.
Receives: Other: Incidence and risk factors of hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: First day of the three-day follow-up period

Secondary outcomes (4)
  1. Left ventricular hypertrophy(g/m^2)

    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. Left ventricular mass index (LVMI,g/m^2)will be measured using echocardiography during the three-day follow-up period.

    Measured: During the three-day follow-up period

  2. Increased arterial stiffness(mm/s)

    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. Brachial-ankle pulse wave velocity(baPWV,mm/s)will be measured with Noninvasive automatic waveform analyzer during the three-day follow-up period.

    Measured: During the three-day follow-up period

  3. Carotid artery wall thickening(mm)

    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. Carotid Intima media thickness (IMT,mm)will be measured using Color Doppler Ultrasound Diagnostic System during the three-day follow-up period.

    Measured: During the three-day follow-up period

  4. Microalbuminuria(mg/24h)

    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. On the second day,24-hour urinary will be collected and the concentrations of microalbuminuria in the urine sample will be measured with Hitachi biochemical analyzer.The 24-h microalbuminuria(mg/24h)of each subject is calculated as the concentration of microalbuminuria multiplied by the 24-h urine volume of each individual.

    Measured: Second day of the three-day follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,298 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02734472
Sponsor's protocol ID
XJTU1AF-CRF-2015-006
Acronym
C-BPCS
Status last verified
Sep 2017
First submitted
22 Mar 2016
Last updated
2 Oct 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 22978814
  • 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.

    PubMed 23059770
  • Yang H, Guo T, Liu Z, Yang L, Yang Y, Xie J, Ren J, He M, Chu C, Li C, Yan Y, Sun Y, Wang D, Hu G, Du M, Jia H, Wang M, Zhao M, Xi B, Mu J. Sensitive periods of BMI change from childhood to adulthood on subclinical cardiovascular outcomes: a 36-year prospective cohort study. BMC Med. 2026 Feb 27;24(1):199. doi: 10.1186/s12916-026-04742-x.

    PubMed 41761194
  • 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.

    PubMed 40932182
  • 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.

    PubMed 39994918
  • Wang Y, Jia H, Gao K, Du MF, Chu C, Wang D, Ma Q, Hu GL, Zhang X, Sun Y, Man ZY, Mu JJ. Renalase alleviates salt-induced kidney necroptosis and inflammation. Hypertens Res. 2024 Oct;47(10):2811-2825. doi: 10.1038/s41440-024-01814-4. Epub 2024 Aug 8.

    PubMed 39117946
  • 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.

    PubMed 39003135
  • Chang MK, Wu GJ, Bao P, Yao S, Du MF, Chu C, Wang D, Jia H, Sun Y, Yan Y, Zhang X, Hu GL, Man ZY, Guo TS, Luo WJ, Li H, Wang Y, Mu JJ. Associations of E-proteinoid 3 receptor genetic polymorphisms with salt sensitivity, longitudinal blood pressure changes, and hypertension incidence in Chinese adults. J Clin Hypertens (Greenwich). 2024 Aug;26(8):955-963. doi: 10.1111/jch.14859. Epub 2024 Jul 1.

    PubMed 38952049
  • 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.

    PubMed 38370536
  • 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.

    PubMed 36039789
  • 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.

    PubMed 32625239
  • 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.

    PubMed 32061408
  • 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.

    PubMed 31728032

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianjun Mu, doctor (0086-029-85323804, mujjun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood pressure value(mmHg) (time frame: First day of the three-day follow-up period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02734472, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.

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