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

Phase 4

• Conditions: Cardiac Death; Aortic Stenosis
• Interventions: Other: Blood test

• Registration Number: NCT02060071
• Lead Sponsor: Kaplan Medical Center

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 Timeline

• Study Start: 2011-07
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-09
• Last Update Submitted: 2014-02-09
• Study First Posted: 2014-02-11
• Last Update Posted: 2014-02-11
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with Aortic stenosis
• Control with aortic stenosis

Exclusion Criteria

• No

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aortic setnsosi	Blood test	blood test
controls	Blood test	blood test

Primary Outcome Measures

Name	Time	Method
Cardiac death or need for intervantion in correlation to endothelial progenitor cells	4 years	We will assess wether endothelial progenitor cells can predict outcome

Trial Locations

Locations (1)

Kaplan Medical Center; 🇮🇱 Rehovot, Israel