Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity

Kaplan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID

Study Details

Study Description

Brief Summary

There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the aortic valve.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood test
Phase 4

Detailed Description

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:
  1. To assess the number and function of endothelial progenitor cellss and apoptotic endothelial progenitor cellss in patients with mild, moderate and severe aortic stenosis.

  2. 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 Design

Study Type:
Anticipated Enrollment :
200 participants
Intervention Model:
Parallel Assignment
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 :
Jul 1, 2011
Actual Primary Completion Date :
Feb 1, 2014
Anticipated Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Aortic setnsosi

blood test

Other: Blood test
Blood test

Other: controls

blood test

Other: Blood test
Blood test

Outcome Measures

Primary Outcome Measures

  1. Cardiac death or need for intervantion in correlation to endothelial progenitor cells [4 years]

    We will assess wether endothelial progenitor cells can predict outcome

Eligibility Criteria


Ages Eligible for Study:
18 Years to 92 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Patients with Aortic stenosis

  • Control with aortic stenosis

Exclusion Criteria:
  • No

Contacts and Locations


Site City State Country Postal Code
1 Kaplan Medical Center Rehovot Israel 7610001

Sponsors and Collaborators

  • Kaplan Medical Center


  • Principal Investigator: Sara Shimoni, MD, Kaplan Medical

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Sara Shimoni, MD, Director of non Invasive Cardiology Unit, Kaplan Medical Center
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • kap118711ctil
First Posted:
Feb 11, 2014
Last Update Posted:
Feb 11, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Sara Shimoni, MD, Director of non Invasive Cardiology Unit, Kaplan Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2014