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

NCT ID: NCT02060071

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-06-30

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.

Conditions

Aortic Stenosis; Cardiac Death

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Aortic setnsosi

blood test

Group Type: OTHER

Blood test

Intervention Type: OTHER

Blood test

controls

blood test

Group Type: OTHER

Blood test

Intervention Type: OTHER

Blood test

Interventions

Blood test

Blood test

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with Aortic stenosis
• Control with aortic stenosis

Exclusion Criteria

• No

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 92 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaplan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sara Shimoni

MD, Director of non Invasive Cardiology Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Shimoni, MD

Role: PRINCIPAL_INVESTIGATOR

Kaplan Medical

Locations

Kaplan Medical Center

Rehovot, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Sara Shimoni, MD

Role: CONTACT

sara_s@clalit.org.il

972-505759131

Facility Contacts

Suzi Trepp

Role: primary

suzitr@clalit.org.il

972-8-9440069

Other Identifiers

kap118711ctil

Identifier Type: -

Identifier Source: org_study_id