Health Monitoring of Elderly Hypertensive Patients

Hypertension Clinical Trial

Official title:

Health Monitoring of Elderly Hypertensive Patients in Tianjin, China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06045403
• Other study ID #: 202381
• Status: Active, not recruiting
• Start date: June 15, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: September 2023
• Source: Centers for Disease Control and Prevention, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to monitor the health of elderly hypertensive patients in Tianjin.

Description:

From June 15th 2023 to August 31st 2023, and December 1st 2023 to February 28th 2024, the researchers will monitor the health indicators of 172 hypertensive patients between the ages of 60 and 65 in Wuqing District, Tianjin.For the sampling stage, two communities will be randomly selected in Wuqing District. The geographical distribution,urbanisation, population size, population structure, economic status, and health service resources of each selected community are in equilibrium.Meanwhile, the distance between the selected communities is greater than 5 km. Based on the list of chronic disease management records, 86 older hypertensive patients (male: female = 1:1) in each community will be involved in monitoring group and blank control group, respectively.Eligible individuals for this trial will be a mean untreated systolic blood pressure of at least 140 mmHg or a mean untreated diastolic blood pressure of at least 90 mmHg, or a mean treated systolic blood pressure of at least 130 mmHg or a mean treated diastolic blood pressure of at least 80 mmHg.Patients with a history of coronary heart disease, heart failure, stroke or diabetes were excluded. For the monitoring stage, different groups are monitored in different ways, including questionnaire surveys,monitoring of health indicators,health checkups and biological sample collection. The exposure temperature, electrocardiography(ECG), and blood pressure indicators will be monitored every day during the study period in the monitoring group,respectively.The blank control group will only monitor the exposure temperature every day. Besides, the study period will be divided into three parts including early, mid, and late period, respectively, and all the patients will have questionnaire surveys, health checkups and biological sample collections once in the early, mid, and late period.Biological biomarkers of inflammation and oxidative stress in the cardiovascular system will be tested. The content of the questionnaire will include individual fundamental information, sleep quality, hypertension medication.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 172
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 65 Years

Eligibility

Inclusion Criteria:

• 60 = 65 years old

• Volunteer to participate in this study

Exclusion Criteria:

• Patients with a history of coronary heart disease, heart failure, stroke or diabetes were excluded.

• Unable to cooperate with follow-up

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• The electrocardiography(ECG) and blood pressure monitoring
The electrocardiography (ECG) and blood pressure indicators will be monitored every day during the study period in the monitoring group.

Locations

Country	Name	City	State
China	National Institute of Environmental Health, Chinese Center for Disease Control and Prevention	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tiantian Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation indicators:Individual fundamental information	Weight and height will be combined to report BMI in kilogram/meter^2 (kg/m^2).	six months
Primary	Observation indicators:Sleep quality	By answering the survey questionnaire, the duration of sleep (hours) was obtained.	six months
Primary	Functional indicators:Blood pressure	Diastolic pressure and systolic pressure in millimetre of mercury (mmHg).	six months
Primary	Functional indicators:Monitoring indicators of electrocardiogram - heartrate	AverageHeartRate in beat per minute(bpm),MaxHeartRate in bpm,MinHeartRate in bpm.	six months
Primary	Functional indicators:Monitoring indicators of electrocardiogram - interval	ECG QT interval inMillisecond(ms),PR interval in ms.	six months
Primary	Functional indicators:Monitoring indicators of electrocardiogram - electrical axis	QRS Electrical axis in degree.	six months
Secondary	Experimental test index:Biomarkers of inflammation in the cardiovascular system - protein	Cardiac troponin in microgram/litre(µg/L),Heart fatty acid binding protein in µg/L,C-reactive protein in µg/L,D-dimer in µg/L,Myoglobin in µg/L.	six months
Secondary	Experimental test index:Biomarkers of inflammation in the cardiovascular system - enzyme	Creatine kinase isoenzyme-MB in unit/liter(U/L).	six months
Secondary	Experimental test index:Biomarkers of inflammation in the cardiovascular system - cytokine	Interleukin-6 in picogram/milliliter(pg/ml).	six months
Secondary	Experimental test index:Biomarkers of inflammation in the cardiovascular system - peptide	B-type natriuretic peptides in picogram/litre(pg/L),NT-proBNP in pg/L.	six months