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ID06898307

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

Led by University Hospital of Ferrara · Updated on 2025-03-27

200

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study focuses on patients evaluated at the specialized Cardiogenetic Center within the Cardiology Department of the University of Ferrara, Italy. It aims to collect detailed clinical, genetic, and electrophysiological information from individuals with suspected or confirmed genetic arrhythmogenic heart conditions. The goal is to improve understanding of the genetic causes and clinical impact of inherited arrhythmias and systemic syndromes, supporting better diagnosis and personalized care. No experimental treatments are involved as this is a registry study. Data collected includes patient demographics, family history, clinical symptoms, diagnostic results, and treatment outcomes. The registry supports long-term follow-up to observe the natural progression of arrhythmogenic disorders and to evaluate the effectiveness of various therapies over time. Participants will be monitored through regular data collection on health outcomes such as death rates, heart failure, and arrhythmia events at one and five years. The study also tracks the need for devices like pacemakers or defibrillators and genetic mutation types. This long-term observational approach helps identify risk factors for adverse events and informs future research and clinical guidelines, with participation lasting several years until the study end date in 2035.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients evaluated at the Cardiogenetic Center of the University of Ferrara in Ferrara, Italy
  • Having a proven cardiogenetic disease
Not Eligible

You will not qualify if you...

  • Refusal to provide informed consent
  • Patients not having a cardiogenetic disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - At the time of genetic analysis

Participants undergo genetic and clinical evaluations to assess their cardiogenetic disease and related arrhythmic conditions.

Long-term Monitoring

Duration - Up to 5 years

Participants are observed over several years to track clinical outcomes, including heart failure, arrhythmias, and survival.

Regular follow-up visits over 5 years

Trial Site Locations

Total: 1 location

1

Department of Cardiology, University Hospital of Ferrara

Ferrara, Italy, 44124

Actively Recruiting

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Research Team

C

Cristina Balla, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death.

Katja Zeppenfeld, Jacob Tfelt-Hansen, Marta de Riva...

https://pubmed.ncbi.nlm.nih.gov/36017572

HRS/EHRA/APHRS expert consensus statement on the diagnosis and management of patients with inherited primary arrhythmia syndromes: document endorsed by HRS, EHRA, and APHRS in May 2013 and by ACCF, AHA, PACES, and AEPC in June 2013.

Silvia G Priori, Arthur A Wilde, Minoru Horie...

https://pubmed.ncbi.nlm.nih.gov/24011539