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Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications (GENERAC)

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ClinicalTrials.gov Identifier: NCT00647088
Recruitment Status : Recruiting
First Posted : March 31, 2008
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Pathophysiology of Aortic Valve Stenosis remains poorly known. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design.

Condition or disease
Aortic Valve Stenosis

Detailed Description:
Aortic valve stenosis (AS) is the most common valvular disease and the second most common indication for cardiac surgery in Western countries. AS has long been considered as a passive and degenerative process. Recent data challenged this concept, showing that AS is an active and highly regulated process with some similarities to atherosclerosis. However, pathophysiology of AS remains poorly understood and preliminary data suggest that genetic factors may be involved. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design (1000 patients with AS and 1500 controls with no evidence of valve disease). For all patients and controls, blood samples including DNA and echocardiography will be performed.

Study Design

Study Type : Observational
Estimated Enrollment : 2200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications
Study Start Date : March 2008
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
aortic stenosis
various age and disease severity
Controls
Controls free of valvular disease


Outcome Measures

Primary Outcome Measures :
  1. Identification of genetic polymorphisms of fetuin-A, matrix-GLA protein, vitamin D receptor [ Time Frame: end of the study ]

Secondary Outcome Measures :
  1. Identification of other genetic polymorphisms [ Time Frame: End of the Study ]

Biospecimen Retention:   Samples With DNA
blood samples DNA Tissue valve

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
case control study Case = patients with aortic valve stenosis Controls = participants free of aortic valve stenosis
Criteria

Patients:

Inclusion criteria :

  • Age >=18 years
  • Pure isolated degenerative aortic valve stenosis

Exclusion criteria :

  • Rheumatic, congenital or post-radiation aortic stenosis
  • Severe renal insufficiency (clearance < 30 ml/min)
  • Aortic insufficiency > or = grade 2/4
  • Other valve disease > or = grade 2/4

Controls

Inclusion criteria :

- Age >=18 years

Exclusion criteria :

  • Known first degree relative with aortic valve stenosis
  • Severe renal insufficiency (clearance < 30 ml/min)
  • Any valve disease > or = grade 2/4
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647088


Locations
France
Assistance Publique - Hôpitaux de Paris, Bichat Hospital Recruiting
Paris, France, 75018
Contact: David MESSIKA-ZEITOUN, MD    01 40 25 66 01 ext 00 33    david.messika-zeitoun@bch.aphp.fr   
Principal Investigator: David Messika-Zeitoun         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: David Messika-Zeitoun, MD Assistance Publique - Hôpitaux de Paris
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00647088     History of Changes
Other Study ID Numbers: P070141
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Aortic Valve stenosis
Genetic
Mineralisation inhibitors

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction