The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01993485

Enrollment

Registered

2013-11-25

Start date

2013-06-30

Completion date

2014-03-31

Last updated

2014-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Aortic Valve Stenosis

Keywords

transaortic valve replacement (TAVI), endothelial function, circulating microparticles

Brief summary

Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades. AVS is independently associated with atheroclerosis risk factors and clinically apparent CV disease indicating that the degeneration of the aortic valve may represent an atheroclerosis-like process involving both, the aortic valve as well as the vascular system, respectivel. It is still unknown whether the endothelial function is affected as an manifestation of the atherosclerotic process, changes in the driving mechanical forces as WSS downstream of the valve, or other factors beyond physical pressure effects. The investigators hypothesized that altered haemodynamics may at least partly be responsible for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI) affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as markers of endothelial integrity.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* aortic valve stenosis * screened for TAVI * written informed consent

Exclusion criteria

* no written informed consent * Patients with acute infections (CRP\> 0.5 mg / dL) * Patients with Atrial Fibrillation * Patients with inflammatory and malignant diseases

Design outcomes

Primary

Measure	Time frame	Description
endothelial function	Changes from Baseline in endothelial function at 3 months	endothelial function will be measured by flow mediated dilation (FMD)
plasma levels of circulating microparticles (MPs)	Changes from Baseline in Plasma Levels of MPs at 3 months	—

Secondary

Measure	Time frame	Description
arterial stiffness	Changes from Baseline in arterial stiffness at 3 months	arterial stiffness will be measured by pulse wave analysis
blood pressure	Changes from Baseline in Hemodynamics at 3 months	—
heart rate	Changes from Baseline in Hemodynamics at 3 months	—

Countries

Germany

Outcome results