Clinical trial NCT01993485: The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function
Official title: The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Aortic Valve Stenosis
Keywords: transaortic valve replacement (TAVI)
endothelial function
circulating microparticles
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with aortic valve stenosis screened for TAVI

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.


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

Primary outcomes:
measure: endothelial function
timeFrame: Changes from Baseline in endothelial function at 3 months
measure: plasma levels of circulating microparticles (MPs)
timeFrame: Changes from Baseline in Plasma Levels of MPs at 3 months
Secondary outcomes:
measure: arterial stiffness
timeFrame: Changes from Baseline in arterial stiffness at 3 months
measure: blood pressure
timeFrame: Changes from Baseline in Hemodynamics at 3 months
measure: heart rate
timeFrame: Changes from Baseline in Hemodynamics at 3 months
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
Study officials:
affiliation: Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
name: Ralf Westenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
name: Malte Kelm, Professor
role: STUDY_CHAIR
References: