NCT05508932

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
75mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Sep 2022Jul 2032

First Submitted

Initial submission to the registry

August 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2032

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2032

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

9.8 years

First QC Date

August 16, 2022

Last Update Submit

February 21, 2026

Conditions

Atrial FibrillationThalassemia

Keywords

Atrial FibrillationThalassemiaThalassaemiaArrhythmiaHemoglobinopathies

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation

    New onset of Atrial Fibrillation documented at ECG

    10 years

Secondary Outcomes (4)

  • Thromboembolism

    10 years

  • Epicardial adipose tissue

    Baseline

  • SGLT2 effect on Hb

    6 months

  • Atrial fibrillation recurrences

    10 years

Study Arms (1)

Beta-thalassemia

Patients with Beta-thalassemia undergoing a cardiological evaluation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Transfusion-dependent Beta-thalassemia patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matteo Bertini

Ferrara, Italy

RECRUITING

Related Publications (2)

  • Marchini F, Mele M, Marchetti E, Rotondo L, Frascaro F, Malagu M, Pavasini R, Tonet E, Serenelli M, Cossu A, Longo F, Lo Monaco M, Bertella E, Campo G, Bertini M. Assessing Cardiac Mechanical Dysfunction in Transfusion-Dependent beta-Thalassemia With History of Atrial Fibrillation: The Role of Speckle Tracking Echocardiography. Echocardiography. 2026 Feb;43(2):e70408. doi: 10.1111/echo.70408.

    PMID: 41674122DERIVED

  • Malagu M, Marchini F, Longo F, Zuin M, Orazio G, Capanni A, Berloni ML, Frascaro F, Tonet E, Cossu A, Culcasi M, Bonsi B, Balla C, Vitali F, Bertini M. Association between epicardial adipose tissue and transfusion-dependent beta-thalassemia. Int J Cardiovasc Imaging. 2025 Nov;41(11):2255-2263. doi: 10.1007/s10554-025-03535-2. Epub 2025 Oct 9.

    PMID: 41065927DERIVED

MeSH Terms

Conditions

Atrial FibrillationThalassemiaArrhythmias, CardiacHemoglobinopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 19, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

July 1, 2032

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

IT(1)