Atrial Fibrillation in Beta-Thalassemia

Sponsor

University Hospital of Ferrara (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05508932

Collaborator

(none)

350

Enrollment

Location

118.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to evaluate the clinical, laboratory and instrumental differences that exist between beta-thalassemia patients with atrial fibrillation and those not affected by arrhythmia.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Thalassemia

Detailed Description

Observational, retrospective and prospective, single-center study, which involves the collection of clinical, laboratory, electrocardiographic and imaging data of patients with major or intermediate thalassemia who have performed, from 2012 to 2022, or will perform in the next 10 years, a cardiological evaluation at the Cardiology Unit of the University Hospital of Ferrara. Patients will be divided into two groups: thalassemia patients with atrial fibrillation (paroxysmal, persistent or permanent) and thalassemia patients with no history of atrial fibrillation.

The objective of the study is to evaluate whether there is a different prevalence of the characteristics analyzed among these patient populations.

Study Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Atrial Fibrillation in Beta-Thalassemia

Anticipated Study Start Date :

Aug 20, 2022

Anticipated Primary Completion Date :

Jun 1, 2032

Anticipated Study Completion Date :

Jul 1, 2032

Arms and Interventions

Arm	Intervention/Treatment
Beta-thalassemia Patients with Beta-thalassemia undergoing a cardiological evaluation

Outcome Measures

Primary Outcome Measures

Atrial fibrillation [10 years]
New onset of Atrial Fibrillation documented at ECG

Secondary Outcome Measures

Thromboembolism [10 years]
Stroke or peripheral embolization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Transfusion-dependent Beta-thalassemia;
Follow-Up at the Cardiology Unit of the University Hospital of Ferrara;
Electrocardiogram performed;
Echocardiogram performed.

Exclusion Criteria:

Age <18 years;
State Of pregnancy;
Inability to give informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Matteo Bertini	Ferrara		Italy

Sponsors and Collaborators

University Hospital of Ferrara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matteo Bertini, Associate Professor, University Hospital of Ferrara

ClinicalTrials.gov Identifier:

NCT05508932

Other Study ID Numbers:

419/2022/Oss/AOUFe

First Posted:

Aug 19, 2022

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Matteo Bertini, Associate Professor, University Hospital of Ferrara

Additional relevant MeSH terms:

Atrial Fibrillation

Thalassemia

beta-Thalassemia

Study Results

No Results Posted as of Aug 19, 2022