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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03482934
Other study ID # LVH in HTN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date September 30, 2020

Study information

Verified date January 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 . Exclusion Criteria: - 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 .

Study Design


Related Conditions & MeSH terms


Intervention

Device:
sphygmomanometer
device used for measurement of brachial blood pressure
mobilogragh
device used for measurement of central blood pressure
Diagnostic Test:
ECG
Electrocardiogram
Echocardiography
Echocardiography

Locations

Country Name City State
Egypt Assiut university of medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 baseline
Primary 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 Base line
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