Hypertension and Injury

NCT ID: NCT02795377

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arterial Hypertension CAD

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

arterial hypertension microparticle endothelial function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

male subjects with arterial hypertension

Measurements will be taken at baseline.

No interventions assigned to this group

male subjects without arterial hypertension and no CAD

Measurements will be taken at baseline.

No interventions assigned to this group

male subjects with hypertensive crises

Measurements will be taken before and after 4 hours and normalization of arterial blood pressure by urapidil.

No interventions assigned to this group

male subjects with stable CAD

Measurements will be taken before and after transfemoral coronary diagnostic angiography.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Klinik für Kardiologie, Pneumologie und Angiologie

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Klinik für Kardiologie, Pneumologie und Angiologie

Principal Investigaor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roberto Sansone, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29684662 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-011

Identifier Type: OTHER

Identifier Source: secondary_id

Hypertension and Injury

Identifier Type: -

Identifier Source: org_study_id