Degenerative Aortic Valve Stenosis Clinical Trial
Official title:
The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function
| Verified date | June 2014 |
| Source | Heinrich-Heine University, Duesseldorf |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf | Dusseldorf |
| Lead Sponsor | Collaborator |
|---|---|
| Heinrich-Heine University, Duesseldorf |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | endothelial function | endothelial function will be measured by flow mediated dilation (FMD) | Changes from Baseline in endothelial function at 3 months | No |
| Primary | plasma levels of circulating microparticles (MPs) | Changes from Baseline in Plasma Levels of MPs at 3 months | No | |
| Secondary | arterial stiffness | arterial stiffness will be measured by pulse wave analysis | Changes from Baseline in arterial stiffness at 3 months | No |
| Secondary | blood pressure | Changes from Baseline in Hemodynamics at 3 months | No | |
| Secondary | heart rate | Changes from Baseline in Hemodynamics at 3 months | No |