Skip to content

Omics in Valvular Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05768594
Acronym
OVERLOAD
Enrollment
30
Registered
2023-03-14
Start date
2019-11-15
Completion date
2023-12-13
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stenosis, Aortic

Keywords

Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement

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.

Interventions

OTHERBlood sample

After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Description of the two serum biomarkers of mitochondrial dysfunction1 yearDescription 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

MeasureTime frameDescription
Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction6 monthsThe 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 monthsThe 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

Countries

Italy

Contacts

Primary ContactLiuzzo LG Giovanna
giovanna.liuzzo@policlinicogemelli.it+39 06/30154187
Backup ContactDaniela DP Pedicino
daniela.pedicino@policlinicogemelli.it+39 06/30154187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026