Hypertension and Injury

Arterial Hypertension Clinical Trial

Official title:

Hypertension, Endothelial Microparticle Release, and Endothelial Function: Role of Pressure, Shear, and Stretch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795377
• Other study ID #: Hypertension and Injury
• Secondary ID: 12-011
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: November 8, 2017
• Start date: April 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Hypertension
• CAD
• Hypertension

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,	Duesseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function	endothelial function measured by flow-mediated dilation (FMD) for Subgroup 1 and 2	Baseline
Primary	Changes in endothelial function	endothelial function measured by flow-mediated dilation (FMD) for Subgroup 3	Baseline and after 4 hours
Primary	Changes in endothelial function	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	Microparticle	Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 1 and 2	Baseline
Secondary	Changes in Microparticle	Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 3	Baseline and after 4 hours
Secondary	Changes Microparticle	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
Secondary	Wall Shear Stress	measured by ultrasound in brachial artery for Subgroup 1 and 2	Baseline
Secondary	Changes in Wall Shear Stress	measured by ultrasound in brachial artery for Subgroup 3	Baseline and 4 hours
Secondary	Changes in Wall Shear Stress	measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography	Baseline and 4 hours after procedure
Secondary	changes in fractional diameter (FDC)	measured by ultrasound in brachial artery for Subgroup 1 and 2	Baseline
Secondary	changes in fractional diameter (FDC)	measured by ultrasound in brachial artery for Subgroup 3	Baseline and after 4 hours
Secondary	Changes in fractional diameter (FDC)	measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography	Baseline and 4 hours after procedure
Secondary	pulse wave velocity	measured for Subgroup 1 and 2	Baseline
Secondary	Changes in pulse wave velocity	measured for Subgroup 3	Baseline and after 4 hours
Secondary	Changes in pulse wave velocity	measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography	Baseline and 4 hours after procedure
Secondary	augmentation index	measured for Subgroup 1 and 2	baseline
Secondary	Changes in augmentation index	measured for Subgroup 3	Baseline and after 4 hours
Secondary	Changes in augmentation index	measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography	Baseline and 4 hours after procedure