Clinical trial NCT02795377: Hypertension and Injury
Official title: Hypertension, Endothelial Microparticle Release, and Endothelial Function: Role of Pressure, Shear, and Stretch
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
CAD
Keywords: arterial hypertension
microparticle
endothelial function
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 80
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with or without arterial hypertension

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: endothelial function
timeFrame: Baseline
measure: Changes in endothelial function
timeFrame: Baseline and after 4 hours
measure: Changes in endothelial function
timeFrame: Baseline and 4 hours after procedure
Secondary outcomes:
measure: Microparticle
timeFrame: Baseline
measure: Changes in Microparticle
timeFrame: Baseline and after 4 hours
measure: Changes Microparticle
timeFrame: Baseline and 4 hours after procedure
measure: Wall Shear Stress
timeFrame: Baseline
measure: Changes in Wall Shear Stress
timeFrame: Baseline and 4 hours
measure: Changes in Wall Shear Stress
timeFrame: Baseline and 4 hours after procedure
measure: changes in fractional diameter (FDC)
timeFrame: Baseline
measure: changes in fractional diameter (FDC)
timeFrame: Baseline and after 4 hours
measure: Changes in fractional diameter (FDC)
timeFrame: Baseline and 4 hours after procedure
measure: pulse wave velocity
timeFrame: Baseline
measure: Changes in pulse wave velocity
timeFrame: Baseline and after 4 hours
measure: Changes in pulse wave velocity
timeFrame: Baseline and 4 hours after procedure
measure: augmentation index
timeFrame: baseline
measure: Changes in augmentation index
timeFrame: Baseline and after 4 hours
measure: Changes in augmentation index
timeFrame: Baseline and 4 hours after procedure
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,
state: NRW
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Roberto Sansone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.