Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity
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|ClinicalTrials.gov Identifier: NCT02060071|
Recruitment Status : Unknown
Verified February 2014 by Sara Shimoni, Kaplan Medical Center.
Recruitment status was: Recruiting
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis Cardiac Death||Other: Blood test||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||June 2014|
Other: Blood test
Other: Blood test
- Cardiac death or need for intervantion in correlation to endothelial progenitor cells [ Time Frame: 4 years ]We will assess wether endothelial progenitor cells can predict outcome
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): NCT02060071
|Contact: Sara Shimoni, MDfirstname.lastname@example.org|
|Kaplan Medical Center||Recruiting|
|Rehovot, Israel, 7610001|
|Contact: Suzi Trepp 972-8-9440069 email@example.com|
|Principal Investigator:||Sara Shimoni, MD||Kaplan Medical|