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Clinical Trials/NCT01993485
NCT01993485
Completed
N/A

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

Heinrich-Heine University, Duesseldorf1 site in 1 country61 target enrollmentJune 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Degenerative Aortic Valve Stenosis
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
61
Locations
1
Primary Endpoint
endothelial function
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
March 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Responsible Party
Principal Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

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

Outcomes

Primary Outcomes

endothelial function

Time Frame: 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)

Time Frame: Changes from Baseline in Plasma Levels of MPs at 3 months

Secondary Outcomes

  • arterial stiffness(Changes from Baseline in arterial stiffness at 3 months)
  • blood pressure(Changes from Baseline in Hemodynamics at 3 months)
  • heart rate(Changes from Baseline in Hemodynamics at 3 months)

Study Sites (1)

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