Automatic and Conventional Methods of Hypertensive Patients Monitoring

NCT06929728 | Not Yet Recruiting

• 1 other identifier: Hypertension close monitoring
• Study Type: observational
• Target: 620
• Locations: 0 countries
• Sites: N/A

Brief Summary

comparing automatic blood pressure measurments methods with conventional office methods in follow up and monitoring of hypertensive patients and predicting hypertension mediated organ damage .

Conditions

Primary Hypertension

Keywords

HTN , HMOD ,BP , LVH ,LAE

Outcome Measures

Primary Outcomes (1)

• predictive accuracy of automatic blood pressure measurments versus conventional office based measurments in identifying patient at risk of hypertension mediated organ damage [HMOD] .

  this outcomes will be assessed by measuring systolic and diastolic blood pressure using both automated devices \[eg omron HEM -907\] and conventional manual sphygmomanometers in a seated postion ,after 5 minutes of rest .measurments will be taken in duplicate on two separate visits ,one week apart and the average readings will be used for analysis .the presence of HMOD will be evaluated through echocardiographic assessment of left ventricular hypertrophy \[LVH \] and microalbuminuria .correlation and predictive value \[ sensitivity , specificity\] will be calculated to compare both methods

  over 6 months follow up period

Study Arms (2)

Group 1

this group use office conventional methods of blood pressure measurments 3 separate readings at different visits

Device: blood pressure measurments devices

group 2

divided into 2 groups 1. st group used home methods twice daily in morning and in evening using cuff digital machine 2. nd group use unattended automatic office blood pressure measurments in 3 readings

Device: blood pressure measurments devices

Interventions

blood pressure measurments devices DEVICE

measure arterial blood pressure by arm cuff devises

Group 1; group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A calculated minimum sample of 620 male and female hypertensive patients aged more than 18 years old recruited from outpatient clinic of assiut cardiology departement will be randomly assigned 1:1 design.

You may qualify if:

• Patients who were screening for suspected hypertention or white coat hypertention .
• medically underserved population .
• primary arterial hypertention .
• high risk hypertensive patients \[resistant hypertension ,patients with poor medication adherance \]

You may not qualify if:

• patients with secondary causes of hypertention
• patients with other cardiac diseases \[heart faliure ,valvular heart diseases \]
• chronic illness affect blood pressure as chronic kideny disease .

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

vereena karam william, resident doctor

CONTACT

+201282212788; vereenakaram@gmail.com

Noha mouhamed gamal, assistant lecture

CONTACT

+201002295166

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04