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OpenTrials
Completed

NCT Number: NCT01993485

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. endothelial function

    Time frame: Changes from Baseline in endothelial function at 3 months

    endothelial function will be measured by flow mediated dilation (FMD)

  2. plasma levels of circulating microparticles (MPs)

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

Secondary outcomes

  1. arterial stiffness

    Time frame: Changes from Baseline in arterial stiffness at 3 months

    arterial stiffness will be measured by pulse wave analysis

  2. blood pressure

    Time frame: Changes from Baseline in Hemodynamics at 3 months

  3. heart rate

    Time frame: Changes from Baseline in Hemodynamics at 3 months

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.