跳至主要内容
临床试验/NCT06898307
NCT06898307招募中不适用

Utility of Gene Test Analysis for Diagnosis, Prognosis and Treatment of Patients With Genetic Arrhythmic Heart Disease: the ARRHYTHMIC GENE-HEART

University Hospital of Ferrara1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
All-cause of death

研究概览

简要总结

The goal of this observational study is to enroll all patients evaluated at the specialized Cardiogenetic Center within the Cardiology Department of the University of Ferrara, Italy. The primary aim of the registry is to collect comprehensive clinical, genetic, and electrophysiological data from individuals with suspected or confirmed arrhythmogenic conditions. By systematically documenting patient demographics, family history, clinical presentations, diagnostic findings, and treatment outcomes, the registry seeks to enhance our understanding of the genetic basis and clinical implications of genetically driven arrhythmias and systemic syndromes. This registry will facilitate long-term follow-up of enrolled patients to assess the natural history of arrhythmogenic disorders and the effectiveness of various therapeutic interventions. Additionally, it aims to identify potential risk factors associated with adverse outcomes, such as sudden cardiac death or major arrhythmic events.

详细描述

Cardiogenetics is essential in daily clinical practice, providing critical insights into the genetic basis of inherited cardiovascular conditions. This knowledge enables more accurate diagnoses, risk assessments, and personalized management strategies for patients. By understanding the genetic underpinnings of arrhythmias and other heart diseases, healthcare providers can identify at-risk individuals and their family members, facilitating early intervention and preventive measures. Establishing an observational registry for these conditions is vital, as it systematically collects data on patient demographics, clinical presentations, genetic findings, and treatment outcomes. This comprehensive database enhances our understanding of the natural history and variability of genetic cardiovascular disorders while supporting research efforts aimed at developing improved diagnostic tools and therapeutic approaches. Ultimately, such a registry can enhance patient care by informing clinical guidelines and fostering collaboration among clinicians, geneticists, and researchers in the field.

Therefore, the goal of this observational study is to gather extensive clinical, genetic, and electrophysiological data from individuals with suspected or confirmed arrhythmogenic conditions. By systematically documenting patient demographics, family history, clinical presentations, diagnostic findings, and treatment outcomes, the registry aims to deepen our understanding of the genetic basis and clinical implications of genetically driven arrhythmias and systemic syndromes.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients evaluated at the Cardiogenetic Center of the University of Ferrara in Ferrara, Italy.
  • •Having a proven cardiogenetic disease

排除标准

  • •Refuse to provide informed consents
  • •Patients not having a cardiogenic disease

结局指标

主要结局

All-cause of death

时间窗: At one and 5 years (end of the study)

The investigators will monitor patient's all causes death

Cardiovascular-related death

时间窗: At one and 5 years (end of the study)

The investigators will monitor patient's all causes death

次要结局

  • Onset/worsening of atrial tachyarrhythmias(At one and 5 years (end of the study))
  • Onset or worsening heart faillure(At one and 5 years (end of the study))
  • Onset/worsening of ventricular tachyarrhythmias(At one and 5 years (end of the study))
  • Need for PM/ICD(At one and 5 years (end of the study))
  • Types of genetic mutations(At the time of genetic analysis)

研究者

发起方
University Hospital of Ferrara
申办方类型
Other
责任方
Sponsor

研究点 (1)

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