跳至主要内容
临床试验/NCT05724225
NCT05724225进行中(未招募)不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Protein expression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Protein expression

时间窗: 1 years

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

次要结局

  • Correlation between clinical data and diagnostic imaging markers(6 months)
  • Correlation between circulating protein biomarkers and diagnostic parameters(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedicino Daniela

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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