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

Completed

• Conditions: Degenerative Aortic Valve Stenosis

• Registration Number: NCT01993485
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-25
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf; 🇩🇪 Dusseldorf, Germany