- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06929728
Automatic and Conventional Methods of Hypertensive Patients Monitoring
April 8, 2025 updated by: vereena karam william hanna, Assiut University
Copmaring Automatic Blood Preesure Measurments To Conventional Office Readings For Monitoring Hypertensive Patients And Predicting Hypertention Mediated Organ Damage
comparing automatic blood pressure measurments methods with conventional office methods in follow up and monitoring of hypertensive patients and predicting hypertension mediated organ damage .
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Close monitoring of hypertensive patients using home and ambulatory blood pressure measurments and its role in predicting hypertention mediated organ damage.
Echocardiography assessment for hypertensive patients and its important role in early detection and prevention of changes such as left ventricular hypertrophy,left atrial enlargement ,systolic and diastolic dysfunction and left ventricular mass .
Microalbumiuria and early detection of renal impairment.
Important role of close monitoring in management and control of hypertention and reduction of hypertensive emergencies and improvement of outcomes ,addherence to treatment , reduce of office consultation , improvement of psycosochial life ,reduce hospitalization cost and mortality rates .
Digital apps has a good role in improve healthy life style and rapid detection of blood presssure changes during daily activities.
Study Type
Observational
Enrollment (Estimated)
620
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: vereena karam william, resident doctor
- Phone Number: +201282212788
- Email: vereenakaram@gmail.com
Study Contact Backup
- Name: Noha mouhamed gamal, assistant lecture
- Phone Number: +201002295166
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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.
Description
Inclusion Criteria:
- 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 ]
Exclusion Criteria:
- 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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
this group use office conventional methods of blood pressure measurments 3 separate readings at different visits
|
measure arterial blood pressure by arm cuff devises
|
|
group 2
divided into 2 groups
|
measure arterial blood pressure by arm cuff devises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
predictive accuracy of automatic blood pressure measurments versus conventional office based measurments in identifying patient at risk of hypertension mediated organ damage [HMOD] .
Time Frame: over 6 months follow up period
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 25, 2025
First Submitted That Met QC Criteria
April 8, 2025
First Posted (Actual)
April 16, 2025
Study Record Updates
Last Update Posted (Actual)
April 16, 2025
Last Update Submitted That Met QC Criteria
April 8, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypertension close monitoring
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.