Omics in Valvular Disease (OVERLOAD)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Stenosis, Aortic

Treatments: Other: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT05768594

2821

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

Patients with aortic stenosis, surgical valve replacement

Description:

15 patients undergoing surgical valve replacement (SAVR)

Treatment:

Other: Blood sample

Patients with aortic stenosis, undergoing transcatheter aortic valve implantation

Description:

15 patients undergoing transcatheter aortic valve replacement (TAVR)

Treatment:

Other: Blood sample