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

Hypertension Clinical Trial

— C-BPCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02734472
• Other study ID #: XJTU1AF-CRF-2015-006
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2016
• Last updated: September 28, 2017
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jianjun Mu, doctor
• Phone: 0086-029-85323804
• Email: mujjun[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 "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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5298
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Incidence and risk factors of hypertension
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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During the three-day follow-up period
Secondary	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.	During the three-day follow-up period
Secondary	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.	During the three-day follow-up period
Secondary	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.	Second day of the three-day follow-up period