Aortic StenosisNCT02890407
Genetics of Aortic Stenosis: From Family Forms to the Common Forms
An observational study of Aortic Stenosis, run by Nantes University Hospital at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis
- How many people
- 1,987 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
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.
- Conditions
- Aortic Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
identify the genetic factors involved in the occurrence of aortic stenosis
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 1,987 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890407
- Sponsor's protocol ID
- PROG/09/61
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Boureau AS, Karakachoff M, Le Scouarnec S, Capoulade R, Cueff C, de Decker L, Senage T, Verhoye JP, Baufreton C, Roussel JC, Dina C, Probst V, Schott JJ, Le Tourneau T. Heritability of aortic valve stenosis and bicuspid enrichment in families with aortic valve stenosis. Int J Cardiol. 2022 Jul 15;359:91-98. doi: 10.1016/j.ijcard.2022.04.022. Epub 2022 Apr 13.
PubMed 35427703
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Aortic Stenosis: From Family Forms to the Common Forms
- ClinicalTrials.gov ID
- NCT02890407
- Acronym / sponsor ID
- PROG/09/61
- Conditions
- Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,987 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- Criteria has reached:
- criteria not met
Key exclusion criteria (6 listed)
- Patients who did not sign the consent
- Non degenerative aortic stenosis or for which another cause could be found.
- Bicuspid aortic valve
- Severe renal impairment
- Severe Hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
identify the genetic factors involved in the occurrence of aortic stenosis
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 35427703Boureau AS, Karakachoff M, Le Scouarnec S, Capoulade R, Cueff C, de Decker L, Senage T, Verhoye JP, Baufreton C, Roussel JC, Dina C, Probst V, Schott JJ, Le Tourneau T. Heritability of aortic valve stenosis and bicuspid enrichment in families with aortic valve stenosis. Int J Cardiol. 2022 Jul 15;359:91-98. doi: 10.1016/j.ijcard.2022.04.022. Epub 2022 Apr 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Nantes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify the genetic factors involved in the occurrence of aortic stenosis (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.