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OVERLOAD: Omics in Valvular Disease

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05768594
Collaborator
(none)
30
Enrollment
1
Location
48.9
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood sample

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Omics in Valvular Disease: Biomarkers of Cardiac Remodeling, Left Ventricular Function, Intensive Care Unit Outcome, and Doppler Echocardiography (OVERLOAD)
Actual Study Start Date :
Nov 15, 2019
Actual Primary Completion Date :
Nov 5, 2020
Anticipated Study Completion Date :
Dec 13, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients with aortic stenosis, surgical valve replacement

15 patients undergoing surgical valve replacement (SAVR)

Other: Blood sample
After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method
Other Names:
  • Color Doppler echocardiogram

    		•
    Patients with aortic stenosis, undergoing transcatheter aortic valve implantation

    15 patients undergoing transcatheter aortic valve replacement (TAVR)

    Other: Blood sample
    After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method
    Other Names:
  • Color Doppler echocardiogram

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Gemelli Roma Italy 00168

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liuzzo Giovanna, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05768594
    Other Study ID Numbers:
    • 2821
    First Posted:
    Mar 14, 2023
    Last Update Posted:
    Mar 20, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Liuzzo Giovanna, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Transcatheter Aortic Valve Replacement
    Surgical Aortic Valve Replacement
    Additional relevant MeSH terms:
    Aortic Valve Stenosis

    Study Results

    No Results Posted as of Mar 20, 2023