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Arterial HypertensionNCT02795377

Hypertension and Injury

An observational study of Arterial Hypertension and CAD, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 80 years, men only
Conditions the study is for
Arterial Hypertension, CAD
How many people
80 participants
Where
1 siteGermany
Study dates
Apr 2016to Nov 2017
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 50 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with or without arterial hypertension

Who may be able to join

  • male subjects with or without arterial hypertension, hypertensive crises, stable CAD
  • written informed consent

Who cannot join

  • subjects with manifest peripheral artery, or cerebrovascular disease, acute inflammation (CRP>0.6 mg/dl), malignancies, arrhythmias

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

    Düsseldorf, North Rhine-Westphalia, 40225

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Keywords
arterial hypertension, microparticle, endothelial function
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02795377
Study groupRoleWhat they receive
male subjects with arterial hypertensionMeasurements will be taken at baseline.
male subjects without arterial hypertension and no CADMeasurements will be taken at baseline.
male subjects with hypertensive crisesMeasurements will be taken before and after 4 hours and normalization of arterial blood pressure by urapidil.
male subjects with stable CADMeasurements will be taken before and after transfemoral coronary diagnostic angiography.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. endothelial function

    endothelial function measured by flow-mediated dilation (FMD) for Subgroup 1 and 2

    Measured: Baseline

  2. Changes in endothelial function

    endothelial function measured by flow-mediated dilation (FMD) for Subgroup 3

    Measured: Baseline and after 4 hours

  3. Changes in endothelial function

    endothelial function measured by flow-mediated dilation (FMD) for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Measured: Baseline and 4 hours after procedure

Secondary outcomes (15)

  1. Microparticle

    Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 1 and 2

    Measured: Baseline

  2. Changes in Microparticle

    Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 3

    Measured: Baseline and after 4 hours

  3. Changes Microparticle

    Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Measured: Baseline and 4 hours after procedure

  4. Wall Shear Stress

    measured by ultrasound in brachial artery for Subgroup 1 and 2

    Measured: Baseline

  5. Changes in Wall Shear Stress

    measured by ultrasound in brachial artery for Subgroup 3

    Measured: Baseline and 4 hours

  6. Changes in Wall Shear Stress

    measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Measured: Baseline and 4 hours after procedure

  7. changes in fractional diameter (FDC)

    measured by ultrasound in brachial artery for Subgroup 1 and 2

    Measured: Baseline

  8. changes in fractional diameter (FDC)

    measured by ultrasound in brachial artery for Subgroup 3

    Measured: Baseline and after 4 hours

  9. Changes in fractional diameter (FDC)

    measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Measured: Baseline and 4 hours after procedure

  10. pulse wave velocity

    measured for Subgroup 1 and 2

    Measured: Baseline

  11. Changes in pulse wave velocity

    measured for Subgroup 3

    Measured: Baseline and after 4 hours

  12. Changes in pulse wave velocity

    measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Measured: Baseline and 4 hours after procedure

  13. augmentation index

    measured for Subgroup 1 and 2

    Measured: baseline

  14. Changes in augmentation index

    measured for Subgroup 3

    Measured: Baseline and after 4 hours

  15. Changes in augmentation index

    measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Measured: Baseline and 4 hours after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

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
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02795377
Sponsor's protocol ID
Hypertension and Injury
Other IDs
12-011
Status last verified
Nov 2017
First submitted
11 May 2016
Last updated
9 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Sansone R, Baaken M, Horn P, Schuler D, Westenfeld R, Amabile N, Kelm M, Heiss C. Release of endothelial microparticles in patients with arterial hypertension, hypertensive emergencies and catheter-related injury. Atherosclerosis. 2018 Jun;273:67-74. doi: 10.1016/j.atherosclerosis.2018.04.012. Epub 2018 Apr 12.

    PubMed 29684662

Questions about this trial

What is this clinical trial studying?

An observational study of Arterial Hypertension and CAD, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 9 Nov 2017. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

endothelial function (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02795377, which also lists 1 linked publication.

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 9 Nov 2017.

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