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

Brief Title

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

Official Title

Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression, Severity, Symptoms and Left Ventricular Function Assessed by 2D Strain Echocardiography

Brief Summary

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

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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

Cardiac death or need for intervantion in correlation to endothelial progenitor cells

Condition

Aortic Stenosis

Intervention

Blood test

Study Arms / Comparison Groups

 Aortic setnsosi

Description:  blood test

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

Start Date

July 2011

Completion Date

June 2014

Primary Completion Date

February 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with Aortic stenosis

          -  Control with aortic stenosis

        Exclusion Criteria:

          -  No

Gender

All

Ages

18 Years - 92 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sara Shimoni, MD, 972-505759131, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations

NCT ID

NCT02060071

Organization ID

kap118711ctil

Responsible Party

Principal Investigator

Study Sponsor

Kaplan Medical Center

Study Sponsor

Sara Shimoni, MD, Principal Investigator, Kaplan Medical

Verification Date

February 2014