HTNNCT03482934
Predictors of Left Ventricular Hypertrophy in Hypertensive Patients in Assiut Governorate
An observational study of HTN and Hypertrophy, Left Ventricular, run by Assiut University at 1 site in Egypt.
Trial summary
To recognize predictors of left ventricular hypertrophy in hypertensive patients in Assiut government \& to recognize the prognostic effect of central blood pressure measurement versus office brachial blood pressure measurement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HTN, Hypertrophy, Left Ventricular
- What is being tested?
- sphygmomanometer, mobilogragh and ECG
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertensive patient recorded in our outpatient clinic during the last two years will be included retrospectively \& new hypertensive patients presenting to our outpatient clinic will be included prospectively for 1 year .
Who may be able to join
- Hypertensive patient recorded in our outpatient clinic during the last two years will be included retrospectively \& new hypertensive patients presenting to our outpatient clinic will be included prospectively for 1 year .
Who cannot join
- Patient aged less than 18 year old.
- Patients from outside Assiut government .
- Ischemic heart diasease .
- Heart failure .
- Cerebrovascular stroke .
- Diabetes mellitus .
- Patients on regular dialysis .
Trial locations and contacts
1 site in 1 country.
About this study
To recognize predictors of left ventricular hypertrophy in hypertensive patients in Assiut government \& to recognize the prognostic effect of central blood pressure measurement versus office brachial blood pressure measurement.
Read the detailed description
Many cohort studies have demonstrated that hypertension is a strong risk factor for total mortality and cardiovascular disease (CVD) in both developing and developed countries.
Although brachial blood pressure (BP) mea¬surements have been used for over a century more and more data suggest that measuring of brachial BP has important limitations. First, a few office BP readings may not be representa¬tive of BP during a patient's daily life. Second, brachial BP may differ from systolic BP mea¬sured at the level of the ascending aorta, i.e. central BP, which is responsible for left ventri¬cle afterload and determines blood flow through coronary and brain arteries .
Recent data from the Strong Heart Study confirm earlier results from smaller studies on high-risk patients that central pulse pressure is superior to brachial pulse pressure in the prediction of further cardiovascular events.
The results of the Conduit Artery Function Evaluation (CAFE) study reminded clinicians of the importance of CBP. Those results demonstrated significant differences in CBP (central SBP and PP) between patient groups treated with different antihypertensive regimens even though peripheral BP levels were comparably lowered, and suggested the potential superiority of CBP to cuff brachial BP in cardiovascular prognostic predictive value in hypertensive patients.
Modifiable risk factors for CVD that are common among adults with hypertension include cigarette smoking/tobacco smoke exposure, DM, dyslipidemia (including high levels of low-density lipoprotein cholesterol or hypercholesterolemia, high levels of triglycerides, and low levels of high-density lipoprotein cholesterol), overweight/obesity, physical inactivity/low fitness level, and unhealthy diet .
There are clear examples around the world of ethnic variations in response to drug therapies epitomized by the benefits of thiazide diuretics and calcium channel blockers in lowering BP in blacks and perhaps in older people of all races, whereas blockers of the renin angiotensin system and β-adrenoceptor receptor blockers are just as effective in some other populations.
Urbanization is a factor that profoundly affects BP patterns. In developed countries, hypertension is more common in rural populations than in urban. This pattern is reversed in developing, lower-, and middle-income countries where the first impact of rising rates of hypertension is seen in urban communities.
- Conditions
- HTN, Hypertrophy, Left Ventricular
- Being tested
- sphygmomanometer, mobilogragh, ECG, Echocardiography
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sphygmomanometerDevice
device used for measurement of brachial blood pressure
mobilograghDevice
device used for measurement of central blood pressure
ECGDiagnostic test
Electrocardiogram
EchocardiographyDiagnostic test
Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| hypertensive patients | Not described Receives: Device: sphygmomanometer; Device: mobilogragh; Diagnostic Test: ECG; Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between brachial blood pressure (measured by sphygmomanometer ) and left ventricular mass index measured by echocardiography to recognize predictors of left ventricular hypertrophy in HTN patients
Measured: baseline
Correlation between non invasive central blood pressure (measured by mobilograph ) and left ventricular mass index (measured by echocardiography) to recognize predictors of left ventricular hypertrophy in HTN patients
Measured: Base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Oct 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HTNStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nardeen Beshay, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482934
- Sponsor's protocol ID
- LVH in HTN
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Left Ventricular Hypertrophy in Hypertensive Patients in Assiut Governorate
- ClinicalTrials.gov ID
- NCT03482934
- Acronym / sponsor ID
- LVH in HTN
- Conditions
- HTN, Hypertrophy, Left Ventricular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 29 Mar 2018 (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.
To recognize predictors of left ventricular hypertrophy in hypertensive patients in Assiut government \& to recognize the prognostic effect of central blood pressure measurement versus office brachial blood pressure measurement.
Detailed description
Many cohort studies have demonstrated that hypertension is a strong risk factor for total mortality and cardiovascular disease (CVD) in both developing and developed countries.
Although brachial blood pressure (BP) mea¬surements have been used for over a century more and more data suggest that measuring of brachial BP has important limitations. First, a few office BP readings may not be representa¬tive of BP during a patient's daily life. Second, brachial BP may differ from systolic BP mea¬sured at the level of the ascending aorta, i.e. central BP, which is responsible for left ventri¬cle afterload and determines blood flow through coronary and brain arteries .
Recent data from the Strong Heart Study confirm earlier results from smaller studies on high-risk patients that central pulse pressure is superior to brachial pulse pressure in the prediction of further cardiovascular events.
The results of the Conduit Artery Function Evaluation (CAFE) study reminded clinicians of the importance of CBP. Those results demonstrated significant differences in CBP (central SBP and PP) between patient groups treated with different antihypertensive regimens even though peripheral BP levels were comparably lowered, and suggested the potential superiority of CBP to cuff brachial BP in cardiovascular prognostic predictive value in hypertensive patients.
Modifiable risk factors for CVD that are common among adults with hypertension include cigarette smoking/tobacco smoke exposure, DM, dyslipidemia (including high levels of low-density lipoprotein cholesterol or hypercholesterolemia, high levels of triglycerides, and low levels of high-density lipoprotein cholesterol), overweight/obesity, physical inactivity/low fitness level, and unhealthy diet .
There are clear examples around the world of ethnic variations in response to drug therapies epitomized by the benefits of thiazide diuretics and calcium channel blockers in lowering BP in blacks and perhaps in older people of all races, whereas blockers of the renin angiotensin system and β-adrenoceptor receptor blockers are just as effective in some other populations.
Urbanization is a factor that profoundly affects BP patterns. In developed countries, hypertension is more common in rural populations than in urban. This pattern is reversed in developing, lower-, and middle-income countries where the first impact of rising rates of hypertension is seen in urban communities.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertensive patients | – | Device: sphygmomanometer, Device: mobilogragh, Diagnostic Test: ECG, Diagnostic Test: Echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive patient recorded in our outpatient clinic during the last two years will be included retrospectively \& new hypertensive patients presenting to our outpatient clinic will be included prospectively for 1 year .
Key inclusion criteria (1 listed)
- Hypertensive patient recorded in our outpatient clinic during the last two years will be included retrospectively \& new hypertensive patients presenting to our outpatient clinic will be included prospectively for 1 year .
Key exclusion criteria (7 listed)
- Patient aged less than 18 year old.
- Patients from outside Assiut government .
- Ischemic heart diasease .
- Heart failure .
- Cerebrovascular stroke .
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 |
|---|---|---|
| sphygmomanometerdevice used for measurement of brachial blood pressure | Device | hypertensive patients |
| mobilograghdevice used for measurement of central blood pressure | Device | hypertensive patients |
| ECGElectrocardiogram | Diagnostic test | hypertensive patients |
| EchocardiographyEchocardiography | Diagnostic test | hypertensive patients |
Primary outcome
Correlation between brachial blood pressure (measured by sphygmomanometer ) and left ventricular mass index measured by echocardiography to recognize predictors of left ventricular hypertrophy in HTN patients
Time frame: baseline
Correlation between non invasive central blood pressure (measured by mobilograph ) and left ventricular mass index (measured by echocardiography) to recognize predictors of left ventricular hypertrophy in HTN patients
Time frame: Base line
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HTN and Hypertrophy, Left Ventricular, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between brachial blood pressure (measured by sphygmomanometer ) and left ventricular mass index measured by echocardiography to recognize predictors of left ventricular hypertrophy in HTN patients (time frame: baseline). The study lists 2 primary outcomes in all. 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 29 Sep 2021.