Atrial Fibrillation in Beta-Thalassemia

Recruiting

• Conditions: Atrial Fibrillation; Thalassemia

• Registration Number: NCT05508932
• Lead Sponsor: University Hospital of Ferrara

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.

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 Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-19
• Study Start: 2022-09-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-07
• Primary Completion: 2032-06-01
• Study Completion: 2032-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	10 years	New onset of Atrial Fibrillation documented at ECG

Secondary Outcome Measures

Name	Time	Method
Thromboembolism	10 years	Stroke or peripheral embolization
Epicardial adipose tissue	Baseline	Thickness of fat depot in epicardial region

Trial Locations

Locations (1)

Matteo Bertini; 🇮🇹 Ferrara, Italy