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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06898307
Enrollment
200
Registered
2025-03-27
Start date
2017-11-01
Completion date
2035-11-01
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmias, Cardiac Disease, Cardiology, Genetic Disease, Genetic Disorder

Keywords

Cardiogenetic

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

University Hospital of Ferrara
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All-cause of deathAt one and 5 years (end of the study)The investigators will monitor patient's all causes death
Cardiovascular-related deathAt one and 5 years (end of the study)The investigators will monitor patient's all causes death

Secondary

MeasureTime frameDescription
Onset/worsening of ventricular tachyarrhythmiasAt 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.
Onset or worsening heart faillureAt 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
Types of genetic mutationsAt the time of genetic analysisTypes of genetic mutations
Need for PM/ICDAt one and 5 years (end of the study)The investigators will evaluate procedural time of different cardiac pacing modalities
Onset/worsening of atrial tachyarrhythmiasAt one and 5 years (end of the study)

Countries

Italy

Contacts

Primary ContactCristina Balla, MD PhD
bllcst@unife.it+39 0532 239886

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026