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

February 27, 2017 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Recruiting
        • Assistance Publique - Hôpitaux de Paris, Bichat Hospital
        • Contact:
        • Principal Investigator:
          • David Messika-Zeitoun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

case control study Case = patients with aortic valve stenosis Controls = participants free of aortic valve stenosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of genetic polymorphisms of fetuin-A, matrix-GLA protein, vitamin D receptor
Time Frame: end of the study
end of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Identification of other genetic polymorphisms
Time Frame: End of the Study
End of the Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: David Messika-Zeitoun, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P070141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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