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

This study is currently recruiting participants.
Verified June 2011 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00647088
First received: March 26, 2008
Last updated: August 3, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Aortic Valve Stenosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Identification of genetic polymorphisms of fetuin-A, matrix-GLA protein, vitamin D receptor [ Time Frame: end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification of other genetic polymorphisms [ Time Frame: End of the Study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples DNA Tissue valve


Estimated Enrollment: 2200
Study Start Date: March 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
aortic stenosis
various age and disease severity
Controls
Controls free of valvular disease

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Assistance Publique - Hôpitaux de Paris

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

Responsible Party: Christophe Aucan, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00647088     History of Changes
Other Study ID Numbers: P070141
Study First Received: March 26, 2008
Last Updated: August 3, 2011
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on June 17, 2013