Comparisonbetween Primary Hypertension Monitoring Methods for Detection of Early Kidney Dysfunction

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03491813
• Collaborator: (none)
• Enrollment: 102
• Anticipated Duration (Months): 10

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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
• Anticipated Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Jun 1, 2020

Outcome Measures

Primary Outcome Measures

1. 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 Central Blood Pressure monitoring through non-invasively using a new well calibrated device named Mobil-O- Graph .( Cuff-based oscillometry at the brachial artery) Automatic blood pressure monitor (Oscillometric) named the OMRON M2 basic® device was provided by Omron Healthcare company.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

• Study Chair: Ahmed Abdel Galeel, MD, Assiut University
• Study Director: Doaa Fouad, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Pickering T. The case for a hybrid sphygmomanometer. Blood Press Monit. 2001 Aug;6(4):177-9.

• Responsible Party: Nader Nabil, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03491813
• Other Study ID Numbers: Hypertension and CKD
• First Posted: Apr 9, 2018
• Last Update Posted: Mar 11, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of Mar 11, 2019