Atrial FibrillationNCT05508932
Atrial Fibrillation in Beta-Thalassemia
An observational study of Atrial Fibrillation and Thalassemia, run by University Hospital of Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Thalassemia
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 1 Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Transfusion-dependent Beta-thalassemia patients
Who may be able to join
- Transfusion-dependent Beta-thalassemia;
- Follow-Up at the Cardiology Unit of the University Hospital of Ferrara;
- Electrocardiogram performed;
- Echocardiogram performed.
Who cannot join
- Age <18 years;
- State Of pregnancy;
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Matteo Bertini
Ferrara
Matteo Bertini, +39 0532236269, brtmtt2@unife.it
About this study
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.
Read the 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.
As secondary outcome, the effect of SGLT2-inhibitors (empaglifozin, dapaglifozin, ...) will be evaluated.
- Conditions
- Atrial Fibrillation, Thalassemia
- Keywords
- Atrial Fibrillation, Thalassemia, Thalassaemia, Arrhythmia, Hemoglobinopathies
- Medical subject headings
- Atrial Fibrillation, Thalassemia, Arrhythmias, Cardiac, Hemoglobinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Beta-thalassemia | Patients with Beta-thalassemia undergoing a cardiological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation
New onset of Atrial Fibrillation documented at ECG
Measured: 10 years
Secondary outcomes (4)
Thromboembolism
Stroke or peripheral embolization
Measured: 10 years
Epicardial adipose tissue
Thickness of fat depot in epicardial region
Measured: Baseline
SGLT2 effect on Hb
rise in hemoblogin levels
Measured: 6 months
Atrial fibrillation recurrences
Recurrences of AF during follow-up
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Jun 2032 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Bertini, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508932
- Sponsor's protocol ID
- 419/2022/Oss/AOUFe
- Status last verified
- Feb 2026
- First submitted
- 16 Aug 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41674122Malagu 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.
PubMed 41065927
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation in Beta-Thalassemia
- ClinicalTrials.gov ID
- NCT05508932
- Acronym / sponsor ID
- 419/2022/Oss/AOUFe
- Conditions
- Atrial Fibrillation, Thalassemia
- Keywords
- Atrial Fibrillation, Thalassemia, Thalassaemia, Arrhythmia, Hemoglobinopathies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2032 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
As secondary outcome, the effect of SGLT2-inhibitors (empaglifozin, dapaglifozin, ...) will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beta-thalassemia | – | –Patients with Beta-thalassemia undergoing a cardiological evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Transfusion-dependent Beta-thalassemia patients
Key inclusion criteria (4 listed)
- Transfusion-dependent Beta-thalassemia;
- Follow-Up at the Cardiology Unit of the University Hospital of Ferrara;
- Electrocardiogram performed;
- Echocardiogram performed.
Key exclusion criteria (3 listed)
- Age <18 years;
- State Of pregnancy;
- Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial fibrillation
Time frame: 10 years
New onset of Atrial Fibrillation documented at ECG
4 secondary outcomes
Thromboembolism
Time frame: 10 years
Epicardial adipose tissue
Time frame: Baseline
SGLT2 effect on Hb
Time frame: 6 months
Atrial fibrillation recurrences
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 41674122Marchini 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.
- Derived from this study: PubMed 41065927Malagu 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.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Thalassemia, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508932, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.