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

NCT06898307 | Recruiting

• 1 other identifier: 307/2023/Oss/AOUFe
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Genetic Disease; Cardiac Disease; Cardiac Arrhythmias; Genetic Disorder; Cardiology

Keywords

Cardiogenetic

Outcome Measures

Primary Outcomes (2)

• All-cause of death

  The investigators will monitor patient's all causes death

  At one and 5 years (end of the study)

• Cardiovascular-related death

  The investigators will monitor patient's all causes death

  At one and 5 years (end of the study)

Secondary Outcomes (5)

• Onset or worsening heart faillure

  At one and 5 years (end of the study)

• Onset/worsening of atrial tachyarrhythmias

  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

Study Arms (1)

Patients with cardiogenetic disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study Population

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Department of Cardiology, University Hospital of Ferrara

Ferrara, 44124, Italy

RECRUITING

Related Publications (4)

• Conte G, Wilde A, Behr ER, Scherr D, Lenarczyk R, Gandjbachkh E, Crotti L, Brugada-Sarquella G, Potpara T. Importance of Dedicated Units for the Management of Patients With Inherited Arrhythmia Syndromes. Circ Genom Precis Med. 2021 Apr;14(2):e003313. doi: 10.1161/CIRCGEN.120.003313. Epub 2021 Apr 2. No abstract available.

  PMID: 33797288 BACKGROUND

• Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.

  PMID: 36017572 BACKGROUND

• Wilde AA, Behr ER. Genetic testing for inherited cardiac disease. Nat Rev Cardiol. 2013 Oct;10(10):571-83. doi: 10.1038/nrcardio.2013.108. Epub 2013 Jul 30.

  PMID: 23900354 BACKGROUND

• Priori SG, Wilde AA, Horie M, Cho Y, Behr ER, Berul C, Blom N, Brugada J, Chiang CE, Huikuri H, Kannankeril P, Krahn A, Leenhardt A, Moss A, Schwartz PJ, Shimizu W, Tomaselli G, Tracy C. 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. Heart Rhythm. 2013 Dec;10(12):1932-63. doi: 10.1016/j.hrthm.2013.05.014. Epub 2013 Aug 30. No abstract available.

  PMID: 24011539 BACKGROUND

MeSH Terms

Conditions

Genetic Diseases, Inborn; Heart Diseases; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristina Balla, MD PhD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Balla, MD PhD

CONTACT

+39 0532 239886; bllcst@unife.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 27, 2025
• Study Start: November 1, 2017
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2035
• Last Updated: March 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)