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

Sponsor
Heinrich-Heine University, Duesseldorf (Other)
Overall Status
Completed
CT.gov ID
NCT01993485
Collaborator
(none)
61
Enrollment
1
Location
9
Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    61 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function
    Study Start Date :
    Jun 1, 2013
    Actual Primary Completion Date :
    Mar 1, 2014
    Actual Study Completion Date :
    Mar 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. endothelial function [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) [Changes from Baseline in Plasma Levels of MPs at 3 months]

    Secondary Outcome Measures

    1. arterial stiffness [Changes from Baseline in arterial stiffness at 3 months]

      arterial stiffness will be measured by pulse wave analysis

    2. blood pressure [Changes from Baseline in Hemodynamics at 3 months]

    3. heart rate [Changes from Baseline in Hemodynamics at 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf Dusseldorf Germany 40225

    Sponsors and Collaborators

    • Heinrich-Heine University, Duesseldorf

    Investigators

    • Principal Investigator: Ralf Westenfeld, MD, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
    • Study Chair: Malte Kelm, Professor, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
    ClinicalTrials.gov Identifier:
    NCT01993485
    Other Study ID Numbers:
    • MP TAVI
    First Posted:
    Nov 25, 2013
    Last Update Posted:
    Jun 4, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
    transaortic valve replacement (TAVI)
    endothelial function
    circulating microparticles
    Additional relevant MeSH terms:
    Aortic Valve Stenosis

    Study Results

    No Results Posted as of Jun 4, 2014