Genetics of Aortic Stenosis: From Family Forms to the Common Forms

Aortic Stenosis Clinical Trial

Official title:

Genetics of Aortic Stenosis: From Family Forms to the Common Forms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890407
• Other study ID #: PROG/09/61
• Status: Completed
• Phase: N/A
• First received: September 1, 2016
• Last updated: September 6, 2016
• Start date: January 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

The association study will compare the allele frequencies of polymorphisms of a single nucleotide (SNP) in the population of individuals with aortic stenosis compared to a control population.

Patients will be included only if they are suffering from a typical form of tight and surgical tricuspid aortic stenosis. Patients will therefore only included if they are suffering from aortic stenosis, the surface is less than 1 cm² and if histological analysis or failing intraoperative findings of the surgeon showed a tricuspid aortic stenosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1987
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Criteria has reached:

• That patients are operated or not, they can be considered as having a degenerative aortic stenosis, patients will be diagnosed with aortic stenosis (aortic area <1 cm) without obvious cause found.

2. criteria not met

• Strictly normal aortic valve by ultrasound in an over 65-year-old patient.

• All patients do not fit into the above two categories are considered as having an unknown phenotype and will not be used in binding assays. In particular, the presence of an aortic sclerosis or even moderate aortic regurgitation can be considered as potentially incipient form of aortic stenosis, patients with this type of anomaly will not be scanned during family analyzes.

Exclusion Criteria:

• Patients who did not sign the consent

• Non degenerative aortic stenosis or for which another cause could be found.

Among the most commonly found causes are:

• Bicuspid aortic valve

• Severe renal impairment

• Severe Hypercholesterolemia

Study Design

Observational Model: Family-Based, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU de Nantes -	Nantes
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identify the genetic factors involved in the occurrence of aortic stenosis		36 months	No