Omics in Valvular Disease: Biomarkers of Cardiac Remodeling, Left Ventricular Function, Intensive Care Unit Outcome, and Doppler Echocardiography (OVERLOAD)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stenosis, Aortic
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Description of the two serum biomarkers of mitochondrial dysfunction
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Liuzzo Giovanna
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Description of the two serum biomarkers of mitochondrial dysfunction
Time Frame: 1 year
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.
Secondary Outcomes
- Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction(6 months)
- Evaluation of gene expression of molecular pathways involved in ventricular remodeling and correlation with echocardiographic parameters of left ventricular performance.(6 months)