Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

Aortic Valve Stenosis Clinical Trial

— GENERAC  

Official title:

Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00647088
• Other study ID #: P070141
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2008
• Last updated: February 27, 2017
• Start date: March 2008
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris, Bichat Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of genetic polymorphisms of fetuin-A, matrix-GLA protein, vitamin D receptor		end of the study
Secondary	Identification of other genetic polymorphisms		End of the Study