Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity
Recruitment status was: Recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression, Severity, Symptoms and Left Ventricular Function Assessed by 2D Strain Echocardiography|
- Cardiac death or need for intervantion in correlation to endothelial progenitor cells [ Time Frame: 4 years ] [ Designated as safety issue: No ]We will assess wether endothelial progenitor cells can predict outcome
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Other: Blood test
Other: Blood test
Degenerative aortic valve (AV) stenosis (AS) is the most common valvular disease and increases in prevalence with age. Severe aortic valve stenosis accounts for considerable disease and death, especially in older patients. Aortic valve stenosis is the primary indication for valve replacement in western countries, and the number will only increase as elderly people are a growing subpopulation. Measures to identify AV disease earlier, to identify factors that influence disease progression and treat AV disease pharmacologically or with less invasive approaches would be a significant improvement over the current standard of care. These advances will only be possible with a better understanding the mechanisms underlying valve development and disease. Preliminary data suggest a novel pathophysiological concept for impaired valvular endothelial cells regeneration, leading to the progression of age-associated calcific AV disease and a potential treatment target is the disrupted endothelial cell layer of the valve leaflet.
The research objectives are:
- To assess the number and function of endothelial progenitor cellss and apoptotic endothelial progenitor cellss in patients with mild, moderate and severe aortic stenosis.
- To study the association between aortic stenosis progression, severity, symptoms and left ventricular function and the number and function of circulating endothelia progenitor cells. By understanding the correlation between valve severity, left ventricular longitudinal function and endothelial progenitor cells we will indentify high risk patients population that need early intervention. We hope to add new information on the pathogenesis of aortic stenosis and to indentify factors that predict disease progression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02060071
|Kaplan Medical Center|
|Rehovot, Israel, 7610001|
|Principal Investigator:||Sara Shimoni, MD||Kaplan Medical|