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Comparisonbetween Primary Hypertension Monitoring Methods for Detection of Early Kidney Dysfunction

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. Identifier: NCT03491813
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : March 11, 2019
Information provided by (Responsible Party):
Nader Nabil, 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

Condition or disease Intervention/treatment
Primary Hypertension Device: oscillometric device

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.

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Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparison Between Centrally Measured Blood Pressure and Automated Blood Pressure Monitoring for Detection of Early Kidney Dysfunction in Patients With Primary Hypertension
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: oscillometric device

    The blood pressure will be measured by the Automatic blood pressure monitor(Oscillometric) named the OMRON M2 basic® device was provided by Omron Healthcare company.

    This monitor uses inflation by Fuzzy-Logic controlled by electric pump and an automatic rapid pressure release valve for the deflation , its cuff allows BP measurements in arm circumference of 22-42 cm. The device measure BP and pulse rate with a pressure range of 0-299 mmHg and pulse rate range of 40-180 beats/min.

Primary Outcome Measures :
  1. Detection of kidney dysfunction in patients with primary hypertension [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will include patients with primary hypertension.

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 .

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

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 identifier (NCT number): NCT03491813

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Contact: Nader Fawzy, MB Bch 00201200394430

Sponsors and Collaborators
Assiut University
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Study Chair: Ahmed Abdel Galeel, MD Assiut University
Study Director: Doaa Fouad Assiut University

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Responsible Party: Nader Nabil, Principal Investigator, Assiut University Identifier: NCT03491813    
Other Study ID Numbers: Hypertension and CKD
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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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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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases