NCT03491813

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

March 19, 2018

Last Update Submit

March 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Detection of kidney dysfunction in patients with primary hypertension

    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.

    1 year

Interventions

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.

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include patients with primary hypertension.

You may qualify if:

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

You may not qualify if:

  • All patients with 2ry hypertension.
  • Diabetic patients.
  • Patients with ESRD on regular dialysis .
  • Patients with creatinineclearance \>30ml/min .
  • collagen diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 2784957BACKGROUND
  • 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.

    PMID: 7875754BACKGROUND
  • Pickering T. The case for a hybrid sphygmomanometer. Blood Press Monit. 2001 Aug;6(4):177-9. doi: 10.1097/00126097-200108000-00002.

    PMID: 11805464BACKGROUND

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Ahmed Abdel Galeel, MD

    Assiut University

    STUDY CHAIR
  • Doaa Fouad

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2018

First Posted

April 9, 2018

Study Start

August 1, 2019

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

March 11, 2019

Record last verified: 2019-03