Atrial Fibrillation in Beta-Thalassemia

Atrial Fibrillation Clinical Trial

Official title:

Atrial Fibrillation in Beta-Thalassemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508932
• Other study ID #: 419/2022/Oss/AOUFe
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: July 1, 2032

Study information

• Verified date: September 2023
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: July 1, 2032
• Est. primary completion date: June 1, 2032
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• beta-Thalassemia
• Thalassemia

Locations

Country	Name	City	State
Italy	Matteo Bertini	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation	New onset of Atrial Fibrillation documented at ECG	10 years
Secondary	Thromboembolism	Stroke or peripheral embolization	10 years
Secondary	Epicardial adipose tissue	Thickness of fat depot in epicardial region	Baseline