Central Blood Pressure in Diabetic HypertensiveNCT03682016
The Effect of Central Blood Pressure on Clinical Outcome in Diabetic Hypertensive Patients in Assiut University Hospitals
An observational study of Central Blood Pressure in Diabetic Hypertensive, run by Assiut University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Blood Pressure in Diabetic Hypertensive
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Mar 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 150 patients attending internal medicine clinics in Assiut University Hospitals
Who may be able to join
- 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
Who cannot join
- Pregnancy or breastfeeding .
- Concomitant therapy of digoxin, lithium, non-depolarizing skeletal muscle relaxants, sex hormone .
- Documented rheumatic diseases such as systemic lupus erythematosus .
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
relation between central systolic blood pressure and the risk of chronic illnesses.
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 ?
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Blood Pressure in Diabetic HypertensiveStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Nader Ramzy Tamer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682016
- Sponsor's protocol ID
- Assiut 93
- Status last verified
- Sep 2018
- First submitted
- 26 Jul 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Central Blood Pressure on Clinical Outcome in Diabetic Hypertensive Patients in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT03682016
- Acronym / sponsor ID
- Assiut 93
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 150 patients attending internal medicine clinics in Assiut University Hospitals
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding .
- Concomitant therapy of digoxin, lithium, non-depolarizing skeletal muscle relaxants, sex hormone .
- Documented rheumatic diseases such as systemic lupus erythematosus .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 ?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Blood Pressure in Diabetic Hypertensive, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lobna F el toni, prof (01009673113, leltoni@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relation between central systolic blood pressure and the risk of chronic illnesses. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.