- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02795377
Hypertension and Injury
November 8, 2017 updated by: Klinik für Kardiologie, Pneumologie und Angiologie
Hypertension, Endothelial Microparticle Release, and Endothelial Function: Role of Pressure, Shear, and Stretch
Membrane microparticles are submicron fragments of membrane vesicles shed from various cell types.
Circulating endothelial microparticles have been proposed as markers of endothelial injury.
However, which mechanical forces contribute to their release is not clear.
Study Overview
Status
Completed
Conditions
Detailed Description
In a first series subjects (50% hypertensives) with and without arterial hypertension and no Coronary Artery Disease (CAD) (n=50) will be recruited.
MP subpopulations will be discriminated by flow cytometry according to the expression of established surface antigens including CD31+/41-, CD144+, and CD62e+.
Besides office and ambulatory 24h blood pressure measurements, pulse wave analysis will be performed to determine central blood pressure, augmentation index (AIX), and pulse wave velocity.
Endothelial function (Flow-mediated dilation, FMD), arterial pulsatile stretch (fractional diameter changes, FDC), and wall-shear-stress (WSS) will be measured in the same segment of the brachial artery (BA) by ultrasound.
In a second series, the investigators will take measurements in subjects with hypertensive crises (SBP>180 mmHg) (n=20) before and after 4h and normalization of arterial BP by urapidil.
In a third series, the investigators will take measurement in subjects with stable CAD (n=10) before and after transfemoral coronary diagnostic angiography.
Study Type
Observational
Enrollment (Actual)
80
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
-
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NRW
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Duesseldorf, NRW, Germany, 40225
- Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,
-
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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
50 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Patients with or without arterial hypertension
Description
Inclusion Criteria:
- male subjects with or without arterial hypertension, hypertensive crises, stable CAD
- written informed consent
Exclusion Criteria:
- subjects with manifest peripheral artery, or cerebrovascular disease, acute inflammation (CRP>0.6 mg/dl), malignancies, arrhythmias
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
Cohorts and Interventions
Group / Cohort |
---|
male subjects with arterial hypertension
Measurements will be taken at baseline.
|
male subjects without arterial hypertension and no CAD
Measurements will be taken at baseline.
|
male subjects with hypertensive crises
Measurements will be taken before and after 4 hours and normalization of arterial blood pressure by urapidil.
|
male subjects with stable CAD
Measurements will be taken before and after transfemoral coronary diagnostic angiography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
endothelial function
Time Frame: Baseline
|
endothelial function measured by flow-mediated dilation (FMD) for Subgroup 1 and 2
|
Baseline
|
Changes in endothelial function
Time Frame: Baseline and after 4 hours
|
endothelial function measured by flow-mediated dilation (FMD) for Subgroup 3
|
Baseline and after 4 hours
|
Changes in endothelial function
Time Frame: Baseline and 4 hours after procedure
|
endothelial function measured by flow-mediated dilation (FMD) for Subgroup 4 before and after transfemoral coronary diagnostic angiography
|
Baseline and 4 hours after procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microparticle
Time Frame: Baseline
|
Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 1 and 2
|
Baseline
|
Changes in Microparticle
Time Frame: Baseline and after 4 hours
|
Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 3
|
Baseline and after 4 hours
|
Changes Microparticle
Time Frame: Baseline and 4 hours after procedure
|
Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 4 before and after transfemoral coronary diagnostic angiography
|
Baseline and 4 hours after procedure
|
Wall Shear Stress
Time Frame: Baseline
|
measured by ultrasound in brachial artery for Subgroup 1 and 2
|
Baseline
|
Changes in Wall Shear Stress
Time Frame: Baseline and 4 hours
|
measured by ultrasound in brachial artery for Subgroup 3
|
Baseline and 4 hours
|
Changes in Wall Shear Stress
Time Frame: Baseline and 4 hours after procedure
|
measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography
|
Baseline and 4 hours after procedure
|
changes in fractional diameter (FDC)
Time Frame: Baseline
|
measured by ultrasound in brachial artery for Subgroup 1 and 2
|
Baseline
|
changes in fractional diameter (FDC)
Time Frame: Baseline and after 4 hours
|
measured by ultrasound in brachial artery for Subgroup 3
|
Baseline and after 4 hours
|
Changes in fractional diameter (FDC)
Time Frame: Baseline and 4 hours after procedure
|
measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography
|
Baseline and 4 hours after procedure
|
pulse wave velocity
Time Frame: Baseline
|
measured for Subgroup 1 and 2
|
Baseline
|
Changes in pulse wave velocity
Time Frame: Baseline and after 4 hours
|
measured for Subgroup 3
|
Baseline and after 4 hours
|
Changes in pulse wave velocity
Time Frame: Baseline and 4 hours after procedure
|
measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography
|
Baseline and 4 hours after procedure
|
augmentation index
Time Frame: baseline
|
measured for Subgroup 1 and 2
|
baseline
|
Changes in augmentation index
Time Frame: Baseline and after 4 hours
|
measured for Subgroup 3
|
Baseline and after 4 hours
|
Changes in augmentation index
Time Frame: Baseline and 4 hours after procedure
|
measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography
|
Baseline and 4 hours after procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Roberto Sansone, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2016
Primary Completion (ACTUAL)
November 1, 2017
Study Completion (ACTUAL)
November 1, 2017
Study Registration Dates
First Submitted
May 11, 2016
First Submitted That Met QC Criteria
June 9, 2016
First Posted (ESTIMATE)
June 10, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 9, 2017
Last Update Submitted That Met QC Criteria
November 8, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypertension and Injury
- 12-011 (OTHER: CTSU)
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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