Clinical trial NCT05768594: Omics in Valvular Disease
Official title: Omics in Valvular Disease: Biomarkers of Cardiac Remodeling, Left Ventricular Function, Intensive Care Unit Outcome, and Doppler Echocardiography (OVERLOAD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stenosis, Aortic
Keywords: Transcatheter Aortic Valve Replacement
Surgical Aortic Valve Replacement
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients admitted to our Department will be enrolled in our study of Cardiovascular Sciences with a diagnosis of severe aortic stenosis and preserved ejection fraction echocardiographic evaluation, divided into two categories:

1. 15 patients undergoing surgical valve replacement (SAVR)
2. 15 patients undergoing transcatheter aortic valve replacement (TAVR)

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.

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.

Primary outcomes:
measure: Description of the two serum biomarkers of mitochondrial dysfunction
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction
timeFrame: 6 months
measure: Evaluation of gene expression of molecular pathways involved in ventricular remodeling and correlation with echocardiographic parameters of left ventricular performance.
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
References: