Comparisonbetween Primary Hypertension Monitoring Methods for Detection of Early Kidney Dysfunction

Primary Hypertension Clinical Trial

Official title:

Comparison Between Centrally Measured Blood Pressure and Automated Blood Pressure Monitoring for Detection of Early Kidney Dysfunction in Patients With Primary Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03491813
• Other study ID #: Hypertension and CKD
• Status: Not yet recruiting
• Start date: August 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: Nader Fawzy, MB Bch
• Phone: 00201200394430
• Email: nader.nabilfawzy87[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Primary Hypertension

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of kidney dysfunction in patients with primary hypertension	Detection of kidney dysfunction by estimation of creatinine clearance using crclcockroft?Gault 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.	1 year