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

Atriogenic Tricuspid Regurgitation, Selected Omics Profile, Multimodality Imaging and Clinical Outcomes (the ATOMIC Study)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tricuspid Valve Insufficiency

Detailed Description

Advances in echocardiography and, in particular, the development of three-dimensional echocardiography have allowed a more accurate analysis of the morphology of the tricuspid valve and a detailed understanding of the mechanisms underlying its insufficiency. From a clinical point of view, ITF is divided into a primary form, less frequent (8-10%), caused by primary alterations of the tricuspid valve apparatus, acquired or congenital, and in a "functional" form, the most frequent, conventionally associated in most cases with coexisting pathologies of the left heart or primitive pathologies of the right heart. More recently, long-lasting persistent atrial fibrillation (AF) has been associated with the development of ITF in the presence of structurally normal valve leaflets, preserved right ventricular size and function, and right atrial dilatation. This form of ITF, defined as "atrial functional", could benefit from a different therapeutic management compared to the classic form, more commonly caused by right ventricular dilatation and dysfunction ("ventricular functional" IT). However, not all patients with AF and tricuspid annulus dilatation develop valvular insufficiency and, on the other hand, with the same valvular annulus dilatation and right atrial size, the prevalence of severe IT forms is extremely variable.

This could depend on different adaptive mechanisms implemented by the valve leaflet tissue that lead to their growth or not in response to atrial remodeling and valve annulus dilatation, representing a key factor in the development and progression of the disease. Atriogenic ITF. If confirmed, these observations could lead to a better prognostic classification and different therapeutic perspectives for patients with AF at risk of developing forms of severe ITF and congestive heart failure.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20149
    • Istituto Auxologico Italiano IRCSS Ospedale San Luca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with persistent atrial fibrillation

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein expression	Evaluation of the protein expression of the altered biomarkers in the 6 study groups	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between circulating protein biomarkers and diagnostic parameters	Analysis of the correlation between circulating protein biomarkers and echocardiographic parameters of mitral and tricuspid valve leaflet remodeling	6 months
Correlation between clinical data and diagnostic imaging markers	Evaluation of the correlation between clinical data (gender, age, AF duration) and echocardiographic imaging markers	6 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Actual): November 7, 2022
• Study Completion (Anticipated): December 29, 2023

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; functional tricuspid valve regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 4424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All informtions about the patient is collected in a case report
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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