Omics in Valvular Disease (OVERLOAD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stenosis, Aortic
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Liuzzo LG Giovanna; Phone Number: +39 06/30154187; Email: giovanna.liuzzo@policlinicogemelli.it
• Study Contact Backup: Name: Daniela DP Pedicino; Phone Number: +39 06/30154187; Email: daniela.pedicino@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the two serum biomarkers of mitochondrial dysfunction	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction	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).	6 months
Evaluation of gene expression of molecular pathways involved in ventricular remodeling and correlation with echocardiographic parameters of left ventricular performance.	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	6 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): November 5, 2020
• Study Completion (Anticipated): December 13, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; Surgical Aortic Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No