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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890407
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.


Condition or disease
Aortic Stenosis

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Study Type : Observational
Actual Enrollment : 1987 participants
Observational Model: Family-Based
Time Perspective: Retrospective
Official Title: Genetics of Aortic Stenosis: From Family Forms to the Common Forms
Study Start Date : January 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. identify the genetic factors involved in the occurrence of aortic stenosis [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  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.
Criteria

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

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): NCT02890407


Locations
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France
CHU Angers
Angers, France
CHU de Nantes -
Nantes, France
CHU de Rennes
Rennes, France
Sponsors and Collaborators
Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02890407    
Other Study ID Numbers: PROG/09/61
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction