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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993485
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, 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.


Condition or disease
Degenerative Aortic Valve Stenosis

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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 : June 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with aortic valve stenosis screened for TAVI
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993485


Locations
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Germany
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
Dusseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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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
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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: November 25, 2013    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
transaortic valve replacement (TAVI)
endothelial function
circulating microparticles
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction