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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
Sponsor:
Information provided by (Responsible Party):
Sara Shimoni, Kaplan Medical Center

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

Condition or disease Intervention/treatment Phase
Aortic Stenosis Cardiac Death 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
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
Primary Completion Date : February 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Aortic setnsosi
blood test
Other: Blood test
Blood test
controls
blood test
Other: Blood test
Blood test



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 92 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with Aortic stenosis
  • Control with aortic stenosis

Exclusion Criteria:


Information from the National Library of Medicine

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


Contacts
Contact: Sara Shimoni, MD 972-505759131 sara_s@clalit.org.il

Locations
Israel
Kaplan Medical Center Recruiting
Rehovot, Israel, 7610001
Contact: Suzi Trepp    972-8-9440069    suzitr@clalit.org.il   
Sponsors and Collaborators
Kaplan Medical Center
Investigators
Principal Investigator: Sara Shimoni, MD Kaplan Medical

Responsible Party: Sara Shimoni, MD, Director of non Invasive Cardiology Unit, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT02060071     History of Changes
Other Study ID Numbers: kap118711ctil
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Sara Shimoni, Kaplan Medical Center:
aortic stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Death
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathologic Processes