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NCT Number: NCT06898307

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

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.

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Key information

Conditions

Genetic Disease Arrhythmias, Cardiac Cardiac Arrhythmias Cardiac Disease Cardiology Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Disorder Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, University Hospital of Ferrara

Ferrara, 44124, Italy

Location status: Recruiting

Location contact

Cristina Balla, MD PhD

CONTACT

[email protected]

+39 0532 239886

Cristina Balla, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. All-cause of death

    Time frame: At one and 5 years (end of the study)

    The investigators will monitor patient's all causes death

  2. Cardiovascular-related death

    Time frame: At one and 5 years (end of the study)

    The investigators will monitor patient's all causes death

Secondary outcomes

  1. Onset or worsening heart faillure

    Time frame: At one and 5 years (end of the study)

    The investigators will assess patient's hemodynamic stability over the years, monitoring the onset or the worsening of heart failure

  2. Onset/worsening of atrial tachyarrhythmias

    Time frame: At one and 5 years (end of the study)

  3. Onset/worsening of ventricular tachyarrhythmias

    Time frame: At one and 5 years (end of the study)

    The investigators will monitor patient's rhythm over the years, assessing the onset or the worsening of ventricular tachyarrhythmias.

  4. Need for PM/ICD

    Time frame: At one and 5 years (end of the study)

    The investigators will evaluate procedural time of different cardiac pacing modalities

  5. Types of genetic mutations

    Time frame: At the time of genetic analysis

    Types of genetic mutations

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Balla, MD PhD

CONTACT

[email protected]

+39 0532 239886

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Important dates

Study start
2017
Primary completion
2025
Study completion
2035
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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