Health Monitoring of Elderly Hypertensive Patients

Sponsor
Tiantian Li (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06045403
Collaborator
(none)
172
1
8.5
20.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The electrocardiography(ECG) and blood pressure monitoring

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
172 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Health Monitoring of Elderly Hypertensive Patients in Tianjin, China
Actual Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
The Monitoring Group

The exposure temperature, electrocardiography(ECG), and blood pressure indicators will be monitored every day during the study period in the monitoring group.

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.

The Blank Control Group

The blank control group will only monitor the exposure temperature every day.

Outcome Measures

Primary Outcome Measures

  1. Observation indicators:Individual fundamental information [six months]

    Weight and height will be combined to report BMI in kilogram/meter^2 (kg/m^2).

  2. Observation indicators:Sleep quality [six months]

    By answering the survey questionnaire, the duration of sleep (hours) was obtained.

  3. Functional indicators:Blood pressure [six months]

    Diastolic pressure and systolic pressure in millimetre of mercury (mmHg).

  4. Functional indicators:Monitoring indicators of electrocardiogram - heartrate [six months]

    AverageHeartRate in beat per minute(bpm),MaxHeartRate in bpm,MinHeartRate in bpm.

  5. Functional indicators:Monitoring indicators of electrocardiogram - interval [six months]

    ECG QT interval inMillisecond(ms),PR interval in ms.

  6. Functional indicators:Monitoring indicators of electrocardiogram - electrical axis [six months]

    QRS Electrical axis in degree.

Secondary Outcome Measures

  1. Experimental test index:Biomarkers of inflammation in the cardiovascular system - protein [six months]

    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.

  2. Experimental test index:Biomarkers of inflammation in the cardiovascular system - enzyme [six months]

    Creatine kinase isoenzyme-MB in unit/liter(U/L).

  3. Experimental test index:Biomarkers of inflammation in the cardiovascular system - cytokine [six months]

    Interleukin-6 in picogram/milliliter(pg/ml).

  4. Experimental test index:Biomarkers of inflammation in the cardiovascular system - peptide [six months]

    B-type natriuretic peptides in picogram/litre(pg/L),NT-proBNP in pg/L.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of Environmental Health, Chinese Center for Disease Control and Prevention Beijing China 100021

Sponsors and Collaborators

  • Tiantian Li

Investigators

  • Study Director: Tiantian Li, National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tiantian Li, professor, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier:
NCT06045403
Other Study ID Numbers:
  • 202381
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023