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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Kaplan Medical Center
Sponsor:
Information provided by (Responsible Party):
Sara Shimoni, Kaplan Medical Center
ClinicalTrials.gov Identifier:
NCT02060071
First received: February 3, 2014
Last updated: February 9, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Aortic Stenosis
Cardiac Death
Other: Blood test
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Kaplan Medical Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Aortic setnsosi
blood test
Other: Blood test
Blood test
Other Name: Blood test
controls
blood test
Other: Blood test
Blood test
Other Name: Blood test

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.
  Eligibility

Ages Eligible for Study:   18 Years to 92 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with Aortic stenosis
  • Control with aortic stenosis

Exclusion Criteria:

  • No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 3, 2014
Last Updated: February 9, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Kaplan Medical Center:
aortic stenosis

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

ClinicalTrials.gov processed this record on October 23, 2014