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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02060071
• Other study ID #: kap118711ctil
• Status: Recruiting
• Phase: Phase 4
• First received: February 3, 2014
• Last updated: February 9, 2014
• Start date: July 2011
• Est. completion date: June 2014

Study information

• Verified date: February 2014
• Source: Kaplan Medical Center
• Contact: Sara Shimoni, MD
• Phone: 972-505759131
• Email: sara_s[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 92 Years

Eligibility

Inclusion Criteria:

• Patients with Aortic stenosis

• Control with aortic stenosis

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Cardiac Death
• Constriction, Pathologic

Intervention

Other:
• Blood test
Blood test

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death or need for intervantion in correlation to endothelial progenitor cells	We will assess wether endothelial progenitor cells can predict outcome	4 years	No