Primary HypertensionNCT06929728
Automatic and Conventional Methods of Hypertensive Patients Monitoring
An observational study of Primary Hypertension, run by Assiut University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- blood pressure measurments devices
- Type of treatment
- Medical device
- How many people
- 620 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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 ]
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Noha mouhamed gamal, assistant lecture contact
About this study
Official title: 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 .
Read the 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.
- Conditions
- Primary Hypertension
- Being tested
- blood pressure measurments devices
- Keywords
- HTN , HMOD ,BP , LVH ,LAE
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure measurments devicesDevice
measure arterial blood pressure by arm cuff devises
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | this group use office conventional methods of blood pressure measurments 3 separate readings at different visits Receives: 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 Receives: Device: blood pressure measurments devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over 6 months follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, vereena karam william hanna, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929728
- Sponsor's protocol ID
- Hypertension close monitoring
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copmaring Automatic Blood Preesure Measurments To Conventional Office Readings For Monitoring Hypertensive Patients And Predicting Hypertention Mediated Organ Damage
- ClinicalTrials.gov ID
- NCT06929728
- Acronym / sponsor ID
- Hypertension close monitoring
- Conditions
- Primary Hypertension
- Keywords
- HTN , HMOD ,BP , LVH ,LAE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
comparing automatic blood pressure measurments methods with conventional office methods in follow up and monitoring of hypertensive patients and predicting hypertension mediated organ damage .
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: blood pressure measurments devicesthis group use office conventional methods of blood pressure measurments 3 separate readings at different visits |
| group 2 | – | Device: blood pressure measurments devicesdivided 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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 ]
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressure measurments devicesmeasure arterial blood pressure by arm cuff devises | Device | Group 1, group 2 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noha mouhamed gamal, assistant lecture contact
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hypertension, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact vereena karam william, resident doctor (+201282212788, vereenakaram@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.