Aortic Regurgitation Clinical Trial
— VAROfficial title:
Investigation of Patients With BAV Requiring Valve and/or Aortic Repair. Correlation of Surgical and ECO Distinctive Features With Histologic and Genetic Findings in Phenotypically Homogeneous Outlier Cases (GISSI VAR)
NCT number | NCT02283970 |
Other study ID # | K11 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2012 |
Est. completion date | July 2017 |
Verified date | August 2018 |
Source | Gruppo di Ricerca GISSI |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective longitudinal study on four small groups of surgical patients affected by: BAV
with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with
isolated stenosis in over 60 year-old patients.
The aim of the study is to select homogeneous small groups of surgical patients with the same
subtype of BAV and same aortic behaviour and identify markers/predictors of
favorable-unfavorable aortic wall evolution to evaluate if there is a BAV phenotype more
likely to be considered at high risk for aortic degeneration.
Status | Completed |
Enrollment | 62 |
Est. completion date | July 2017 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men and women over 18 years-old and under the age of 60 (age selection will prevent from enrolling patient with age-related valve and aortic wall degeneration). For the BAV stenosis group there will be considered patients over 60 years-old: including the most frequent form of BAV disease and the commonest age, this group could be used as a control group compared to the outlier ones. - Echo diagnosis of BAV and indication to surgery: BAV with isolated regurgitation, BAV with normal valvular function but associated aorta dilatation, BAV with both valve regurgitation and aortic dilatation BAV with isolated stenosis - Signed informed consent Exclusion Criteria: - Patient with a previous cardiac or great vessels surgery - coexistent coarctation of the aorta - non-associated cardiac diseases: valve disease (other than aortic), ischemic disease, congenital heart disease. - Marfan syndrome or other connective tissue disorders involving aortic valve and aortic wall disease (history of disease or clinical signs). - Other conditions/circumstances likely to lead to poor study adherence (e.g. psychological or organizational reasons). - Serious disease other than aortic, severely limiting life expectancy. - Patients who refuse to give informed consent |
Country | Name | City | State |
---|---|---|---|
Italy | Casa Di Cura Villa Sant'Anna | Catanzaro | CZ |
Italy | Aou Careggi | Firenze | FI |
Italy | Ospedale Dell'Angelo | Mestre | VE |
Italy | Centro Cardiologico Monzino | Milano | MI |
Italy | Ospedale Niguarda | Milano | MI |
Italy | Ospedale San Raffaele | Milano | MI |
Italy | Ospedale San Camillo | Roma | |
Italy | Irccs Policlinico San Donato | San Donato Milanese | MI |
Italy | Azienda Osp. Univ. S. Giovanni Battista | Torino | |
Italy | Aou Santa Maria Della Misericordia | Udine | UD |
Lead Sponsor | Collaborator |
---|---|
Gruppo di Ricerca GISSI |
Italy,
Merlanti B, De Chiara B, Maggioni AP, Moreo A, Pileggi S, Romeo G, Russo CF, Rizzo S, Martinelli L, Maseri A; VAR Study Group. Rationale and design of GISSI OUTLIERS VAR Study in bicuspid aortic valve patients: prospective longitudinal, multicenter study to investigate correlation between surgical, echo distinctive features, histologic and genetic findings in phenotypically homogeneous outlier cases. Int J Cardiol. 2015 Nov 15;199:180-5. doi: 10.1016/j.ijcard.2015.06.182. Epub 2015 Jul 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mutation in NOTCH1 gene | The strongest causative gene associated with BAV is NOTCH1. Its 34 coding exons will be sequenced to search for variants likely to be causative. The presence of sequence variation will be confirmed using a different method, starting from a new amplification (RFLP or High Resolution Melting-HRM). The pathogeneticity of the mutation will be evaluated screening 500 DNA controls (1000 chromosomes) to estimate the alleles' frequencies (HRM; ABI Prism 7900HT). Finally a familial segregation analysis will be performed to verify the association with the disease. |
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