"Atriogenic Tricuspid Selected, Omics Profile, Multimodality Imaging and Clinical Outcomes"

NCT05724225 | Unknown

• 1 other identifier: 4424
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with ITF and isolated AF, in comparison with patients with ITF from right ventricular remodeling, patients with atriogenic MI and left ventricular remodeling. To achieve these aims, markers obtained from cardiovascular imaging methods, such as 3D echocardiogram, and biomarkers isolated from the peripheral blood of the study participants will be considered.

Conditions

Tricuspid Valve Insufficiency

Keywords

functional tricuspid valve regurgitation; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Protein expression

  Evaluation of the protein expression of the altered biomarkers in the 6 study groups

  1 years

Secondary Outcomes (2)

• Correlation between circulating protein biomarkers and diagnostic parameters

  6 months

• Correlation between clinical data and diagnostic imaging markers

  6 months

Study Arms (6)

First group with atrial fibrillation disease

10 Atrial fibrillation(AF), predominant right atrial dilatation with at least moderate IT

Second group with atrial fibrillation disease and tricuspid insufficiency

10 AF, predominantly right atrial dilatation without TI (or TI no more than mild)

Third group with AF and mitral insufficiency

10 AF, predominantly left atrial dilatation with at least moderate MI

Fourth group with atrial fibrillation and IM

10 AF, predominantly left atrial dilatation without MI (or no more than mild MI)

Fifth group with tricuspid insufficiency

10 IT at least moderate to right ventricular remodeling in patients with pulmonary hypertension

Sixth group with mitral insufficiency

10 MI at least average from left ventricular remodeling from left ventricular dysfunction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with persistent atrial fibrillation

You may qualify if:

• \- Admitted to the Department of cardiological, neurological and metabolic sciences of the San Luca hospital with a diagnosis of persistent atrial fibrillation

You may not qualify if:

• Patient aged \<18 years;
• Pregnancy;
• Chronic inflammatory diseases;
• Autoimmune diseases;
• Tumor diseases;
• Chronic renal failure with eGFR \< 30 mL/min;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Istituto Auxologico Italiano IRCSS Ospedale San Luca

Milan, 20149, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

samle blood to conduct an analysis and evaluate protein expression and Analysis of the correlation between circulating protein biomarkers and echocardiographic parameters

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: October 6, 2021
• Primary Completion: November 7, 2022
• Study Completion: December 29, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)