The Effect of Central Blood Pressure on Clinical Outcome in Diabetic Hypertensive Patients in Assiut University Hospitals

September 20, 2018 updated by: Andrew Nader Ramzy Tamer, Assiut University
In recent decades, some observational studies suggest that peripheral BP measured by brachial artery may not necessarily represent BP measured in the aortic artery which is known as central BP .In addition, some clinical trials also revealed that despite with comparable peripheral BP, patients with high central BP had significantly higher cardiovascular risk compared with those with low central BP indicating that central BP might be an independent predictor for CVD

Study Overview

Status

Unknown

Conditions

Detailed Description

Diabetes mellitus (DM) is amajor risk factor for cardiovascular and renal diseases[1] .It is known about two thirds of diabetic patients died from these complication .Numerous epidemiological studies demonstrate that DM is commonly accompanied with hypertension and patients with diabetes and hypertension have higher renal and cardiovascular risks compared with those with either hypertension or diabetes. Therefore, better evaluating and managing BP in diabetic patients with hypertension is clinically relevant.

Hypertension also is a major risk factor for cardiovascular diseases (CVD) and all-cause mortality . Numerous randomized controlled trials using antihypertensive drugs and meta-analysis demonstrate that lowering peripheral blood pressure (BP) is beneficial for reducing cardiovascular and renal events.

In recent decades, some observational studies suggest that peripheral BP measured by brachial artery may not necessarily represent BP measured in the aortic artery which is known as central BP.

In addition, some clinical trials also revealed that despite with comparable peripheral BP, patients with high central BP had significantly higher cardiovascular risk compared with those with low central BP indicating that central BP might be an independent predictor for CVD

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut Univrtsity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

150 patients attending internal medicine clinics in Assiut University Hospitals

Description

Inclusion Criteria:

  • Patients aged 40 - 60 years old
  • Patients in group A and B are documented to have type 2 DM
  • Patients in group A are documented to have essential hypertension .
  • Hypertensive patients enrolled must be compliant on their treatment for at least one month

Exclusion Criteria:

  • Pregnancy or breastfeeding .
  • Concomitant therapy of digoxin, lithium, non-depolarizing skeletal muscle relaxants, sex hormone .
  • Documented rheumatic diseases such as systemic lupus erythematosus .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relation between central systolic blood pressure and the risk of chronic illnesses.
Time Frame: 2 years
With comparable brachial blood pressure ,Do patients with significantly higher central systolic blood pressure have higher risks to have cardiovascular, peripheral arterial and cerebrovascular diseases or not ?
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

September 20, 2018

First Posted (Actual)

September 24, 2018

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Assiut 93

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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