Comparisonbetween Primary Hypertension Monitoring Methods for Detection of Early Kidney Dysfunction

NCT ID: NCT03491813

Last Updated: 2019-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-06-01

Brief Summary

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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

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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.

Conditions

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Primary Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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oscillometric device

The blood pressure will be measured by the Automatic blood pressure monitor(Oscillometric) named the OMRON M2 basicĀ® 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nader Nabil

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Abdel Galeel, MD

Role: STUDY_CHAIR

Assiut University

Doaa Fouad

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Nader Fawzy, MB Bch

Role: CONTACT

00201200394430

References

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Cornoni-Huntley J, LaCroix AZ, Havlik RJ. Race and sex differentials in the impact of hypertension in the United States. The National Health and Nutrition Examination Survey I Epidemiologic Follow-up Study. Arch Intern Med. 1989 Apr;149(4):780-8.

Reference Type BACKGROUND
PMID: 2784957 (View on PubMed)

Burt VL, Whelton P, Roccella EJ, Brown C, Cutler JA, Higgins M, Horan MJ, Labarthe D. Prevalence of hypertension in the US adult population. Results from the Third National Health and Nutrition Examination Survey, 1988-1991. Hypertension. 1995 Mar;25(3):305-13. doi: 10.1161/01.hyp.25.3.305.

Reference Type BACKGROUND
PMID: 7875754 (View on PubMed)

Pickering T. The case for a hybrid sphygmomanometer. Blood Press Monit. 2001 Aug;6(4):177-9. doi: 10.1097/00126097-200108000-00002.

Reference Type BACKGROUND
PMID: 11805464 (View on PubMed)

Other Identifiers

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Hypertension and CKD

Identifier Type: -

Identifier Source: org_study_id

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