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

K

Kaplan Medical Center

Status and phase

Unknown
Phase 4

Conditions

Cardiac Death
Aortic Stenosis

Treatments

Other: Blood test

Study type

Interventional

Funder types

Other

Identifiers

NCT02060071
kap118711ctil

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 92 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients with Aortic stenosis
  • Control with aortic stenosis

Exclusion criteria

  • No

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Aortic setnsosi
Other group
Description:
blood test
Treatment:
Other: Blood test
controls
Other group
Description:
blood test
Treatment:
Other: Blood test

Trial contacts and locations

1

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Central trial contact

Sara Shimoni, MD

Data sourced from clinicaltrials.gov

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