Comparisonbetween Primary Hypertension Monitoring Methods for Detection of Early Kidney Dysfunction

• Conditions: Primary Hypertension

• Registration Number: NCT03491813
• Lead Sponsor: Assiut University

Brief Summary

The present study aims to show the difference of blood pressure monitored centrally and automated BP monitoring among patients with primary hypertension for early detection of kidney dysfunction

Detailed Description

Hypertension is well known as the silent killer, There is a close relationship between blood pressure levels and the risk of cardiovascular events, strokes and kidney disease.

Diabetes and hypertension cause up to two-thirds of chronic kidney disease , chronic kidney disease is a common condition characterized by evidence of kidney damage or dysfunction.

chronic kidney disease is currently classified based on a patient's estimated glomerular filtration rate and urinary albumin excretion rate , clinicians look for markers of renal damage (e.g., abnormalities of urinary sediment or organ structure) to diagnose chronic kidney disease in people with estimated glomerular filtration rate of \<60 mL/min/1.73 m2.

Age distribution for hypertension showed progressive rise in blood pressure with increasing age. Age-related hypertension appears to be predominantly systolic rather than diastolic. The third NHANES survey reported that the prevalence of hypertension grows significantly with increasing age in all sex and race groups. In another study, the incidence of hypertension appeared to increase approximately 5% for each 10-year interval of age Because Central blood pressure is considered better than peripheral blood pressure in predicting cardiovascular events, due to wave reflections and viscoelastic properties of the arterial wall Now a day several non-mercury techniques have been developed during the last ten years in order to gradually supplant the mercury-auscultatory method, such as the automatic electronic devices using algorithms based on the oscillometric technique.

Over the last ten years , different protocols are used to validate the accuracy of blood pressure measuring devices , several automated devices have been successfully validated using established protocols.

Study Timeline

• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11
• Study Start: 2019-08-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Age between 40 Years to 70 Years old .
2. Patients who have history of primary hypertension either on medical treatment or not .

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Exclusion Criteria

1. All patients with 2ry hypertension.
2. Diabetic patients.
3. Patients with ESRD on regular dialysis .
4. Patients with creatinineclearance >30ml/min .
5. collagen diseases

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of kidney dysfunction in patients with primary hypertension	1 year	Detection of kidney dysfunction by estimation of creatinine clearance using crclcockroftـGault equation.; In patients with primary hypertension and blood pressure will measured by two methods; 1. Central Blood Pressure monitoring through non-invasively using a new well calibrated device named Mobil-O- Graph .( Cuff-based oscillometry at the brachial artery); 2. Automatic blood pressure monitor (Oscillometric) named the OMRON M2 basic® device was provided by Omron Healthcare company.