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

Sponsor

Kaplan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02060071

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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:

To assess the number and function of endothelial progenitor cellss and apoptotic endothelial progenitor cellss in patients with mild, moderate and severe aortic stenosis.
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 Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2011

Actual Primary Completion Date :

Feb 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Aortic setnsosi

blood test

Other: Blood test

Blood test

Other: controls

blood test

Other: Blood test

Blood test

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 92 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with Aortic stenosis
Control with aortic stenosis

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaplan Medical Center	Rehovot		Israel	7610001

Sponsors and Collaborators

Kaplan Medical Center

Investigators

Principal Investigator: Sara Shimoni, MD, Kaplan Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sara Shimoni, MD, Director of non Invasive Cardiology Unit, Kaplan Medical Center

ClinicalTrials.gov Identifier:

NCT02060071

Other Study ID Numbers:

kap118711ctil

First Posted:

Feb 11, 2014

Last Update Posted:

Feb 11, 2014

Last Verified:

Feb 1, 2014

Keywords provided by Sara Shimoni, MD, Director of non Invasive Cardiology Unit, Kaplan Medical Center

aortic stenosis

Additional relevant MeSH terms:

Aortic Valve Stenosis

Constriction, Pathologic

Death

Study Results

No Results Posted as of Feb 11, 2014