Omics in Valvular Disease

Study Overview
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Brief Summary
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The aim of our study is to investigate the effects of impaired left ventricular remodeling on the short- and long-term prognosis in AS partecipants undergoing extracorporeal circulation during valve repair surgery and in partecipants undergoing implantation transcatheter. For the achievement of these purposes, markers obtained from will be considered cardiovascular imaging methods, such as color Doppler echocardiography and isolated biomarkers from peripheral blood and heart tissue.

Detailed Description
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Participation in this study includes, following enrollment, a visit of follow up (6/12 months) on the occasion of a concomitant medical check-up scheduled according to normal clinical practice. During these visits venous and contextual blood samples will be taken echocardiographic examination for re-evaluation of ejection fraction, as per normal practice clinic. The only variant will be the withdrawal of an additional aliquot of blood during the sampling standard blood. All enrolled partecipants will undergo the optimal medical treatment provided by current and more recent guidelines for the treatment of heart valve disease. Joining this study will not result any modification of the current therapy, which will be established by the attending physician according to the correct one clinical practice.

Official Title
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Omics in Valvular Disease: Biomarkers of Cardiac Remodeling, Left Ventricular Function, Intensive Care Unit Outcome, and Doppler Echocardiography (OVERLOAD)

Conditions
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Stenosis, Aortic

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -30 patients with a diagnosis of severe aortic stenosis and preserved ejection fraction to echocardiographic evaluation Exclusion Criteria: inflammatory; infectious diseases; neoplasms; ailments immunological or haematological; treatment with anti-inflammatory drugs except aspirin a low dose (75-160 mg); age > 85 years; advanced chronic kidney disease with filtrate glomerular heart rate (eGFR) estimated by MDRD equation <30 ml/min./1.73 m2.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with aortic stenosis, surgical valve replacement<br>15 patients undergoing surgical valve replacement (SAVR) | Other: Blood sample<br>* After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method<br>* Other names: Color Doppler echocardiogram;|
| Patients with aortic stenosis, undergoing transcatheter aortic valve implantation<br>15 patients undergoing transcatheter aortic valve replacement (TAVR) | Other: Blood sample<br>* After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method<br>* Other names: Color Doppler echocardiogram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the two serum biomarkers of mitochondrial dysfunction | Description of the two serum biomarkers of mitochondrial dysfunction Myeloperoxidase (MPO) and Lactoferrin (LF) and the indices of myocardial performance, systolic and diastolic function of the left ventricle in patients undergoing invasive (SAVR) or non-invasive (TAVR) monitoring. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction | The two serum biomarkers and the myocardial performance indices, of the left ventricular systolic and diastolic function , evaluated in patients undergoing invasive (SAVR) or non-invasive monitoring (TAVR). | 6 months | 
| Evaluation of gene expression of molecular pathways involved in ventricular remodeling and correlation with echocardiographic parameters of left ventricular performance. | The gene expression of the molecular pathways involved in ventricular remodeling and the correlation with echocardiographic parameters of left ventricular performance, will be evaluated through methods: peripheral blood sampling immunochemical analysis evaluation of the oxidant and anti-oxidant capacity in vitro | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement