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

NCT ID: NCT01993485

Last Updated: 2014-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Degenerative Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralf Westenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

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

Malte Kelm, Professor

Role: STUDY_CHAIR

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

Locations

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

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MP TAVI

Identifier Type: -

Identifier Source: org_study_id

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