Omics in Valvular Disease
- Conditions
- Stenosis, Aortic
- Interventions
- Other: Blood sample
- Registration Number
- NCT05768594
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
-30 patients with a diagnosis of severe aortic stenosis and preserved ejection fraction to echocardiographic evaluation
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with aortic stenosis, surgical valve replacement Blood sample 15 patients undergoing surgical valve replacement (SAVR) Patients with aortic stenosis, undergoing transcatheter aortic valve implantation Blood sample 15 patients undergoing transcatheter aortic valve replacement (TAVR)
- Primary Outcome Measures
Name Time Method Description of the two serum biomarkers of mitochondrial dysfunction 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 Outcome Measures
Name Time Method Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction 6 months 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).
Evaluation of gene expression of molecular pathways involved in ventricular remodeling and correlation with echocardiographic parameters of left ventricular performance. 6 months 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
Trial Locations
- Locations (1)
Fondazione Policlinico Gemelli
🇮🇹Roma, Italy