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Predictors of Left Ventricular Hypertrophy in Hypertensive Patients in Assiut Governorate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482934
Recruitment Status : Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Nardeen Beshay, Assiut University

Brief 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.

Condition or disease Intervention/treatment
HTN Hypertrophy, Left Ventricular Device: sphygmomanometer Device: mobilogragh Diagnostic Test: ECG Diagnostic Test: Echocardiography

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Predictors of Left Ventricular Hypertrophy in Hypertensive Patients in Assiut Governorate
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
hypertensive patients Device: sphygmomanometer
device used for measurement of brachial blood pressure

Device: mobilogragh
device used for measurement of central blood pressure

Diagnostic Test: ECG
Electrocardiogram

Diagnostic Test: Echocardiography
Echocardiography




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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 .
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482934


Contacts
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Contact: Nardeen beshay 201014812079 ext 00+20 nardeen.beshay@gmail.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Nardeen Beshay, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03482934    
Other Study ID Numbers: LVH in HTN
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertrophy, Left Ventricular
Hypertrophy
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Cardiovascular Diseases