Diabetes MellitusNCT06951737
Evaluation Of The Effect Of SGLT-2 Inhibitors On Atrial Fibrillation Recurrence In Diabetic Patients
An observational study of Diabetes Mellitus and Atrial Fibrillation (AF), run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
Trial summary
Consecutive DCCV was performed until to achieve 120 patients in SR (60 DM patients who used SGLT-2 inhibitors and 60 DM patients who did not use SGLT-2 inhibitors). Patients defined as SGLT-2 inhibitor user group and control group. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Atrial Fibrillation (AF)
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2022to 2 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with DM and AF who were planned to undergo electrical cardioversion were evaluated for suitability for the study.
Who may be able to join
- patients > 18 years and < 90 years,
- Patient diagnosed with DM
- Patient underwent electrical cardioversion due to AF and was restored to sinus rhythm
Who cannot join
- patient who are not suitable for anticoagulant use,
- have thyroid dysfunction,
- glomerular filtration rate ≤ 25 ml/min/1.73 m²,
- patients whose sinus rhythm cannot be achieved with electrical cardioversion,
- malignancy patients,
- patients with acute or chronic inflammatory disease,
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- patients with peripheral artery disease,
- patients with pacemakers,
- patients with advanced valve stenosis or insufficiency,
- patients who have had coronary bypass surgery,
- patients with percutaneous or surgical bioprosthesis or metallic valve surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Consecutive DCCV was performed until to achieve 120 patients in SR (60 DM patients who used SGLT-2 inhibitors and 60 DM patients who did not use SGLT-2 inhibitors). Patients defined as SGLT-2 inhibitor user group and control group. The two groups were monitored for AF recurrence on the first day, then at one, three, and six months after CV.
- Conditions
- Diabetes Mellitus, Atrial Fibrillation (AF)
- Medical subject headings
- Diabetes Mellitus, Atrial Fibrillation
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 |
|---|---|---|
| SGLT-2 inhibitor user | patients with diabetes mellitus, atrial fibrillation and using SGLT-2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrence
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start2 Oct 2022
- Primary completion2 Apr 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951737
- Sponsor's protocol ID
- Bursa SUAM
- Status last verified
- Jun 2025
- First submitted
- 20 Apr 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yarar M, Ari H, Ari S, Tutuncu A, Melek M, Bozat T. Evaluation of the effect of SGLT-2 inhibitors on atrial fibrillation recurrence in diabetic patients. Expert Opin Pharmacother. 2025 Aug;26(11-12):1343-1349. doi: 10.1080/14656566.2025.2527189. Epub 2025 Jul 3.
PubMed 40579747
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of SGLT-2 Inhibitors On Atrial Fibrillation Recurrence In Diabetic Patients
- ClinicalTrials.gov ID
- NCT06951737
- Acronym / sponsor ID
- Bursa SUAM
- Conditions
- Diabetes Mellitus, Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 30 Apr 2025 (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.
Consecutive DCCV was performed until to achieve 120 patients in SR (60 DM patients who used SGLT-2 inhibitors and 60 DM patients who did not use SGLT-2 inhibitors). Patients defined as SGLT-2 inhibitor user group and control group. The two groups were monitored for AF recurrence on the first day, then at one, three, and six months after CV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGLT-2 inhibitor user | – | –patients with diabetes mellitus, atrial fibrillation and using SGLT-2 inhibitor |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with DM and AF who were planned to undergo electrical cardioversion were evaluated for suitability for the study.
Key inclusion criteria (3 listed)
- patients > 18 years and < 90 years,
- Patient diagnosed with DM
- Patient underwent electrical cardioversion due to AF and was restored to sinus rhythm
Key exclusion criteria (11 listed)
- patient who are not suitable for anticoagulant use,
- have thyroid dysfunction,
- glomerular filtration rate ≤ 25 ml/min/1.73 m²,
- patients whose sinus rhythm cannot be achieved with electrical cardioversion,
- malignancy patients,
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 recurrence
Time frame: six month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Derived from this study: PubMed 40579747Yarar M, Ari H, Ari S, Tutuncu A, Melek M, Bozat T. Evaluation of the effect of SGLT-2 inhibitors on atrial fibrillation recurrence in diabetic patients. Expert Opin Pharmacother. 2025 Aug;26(11-12):1343-1349. doi: 10.1080/14656566.2025.2527189. Epub 2025 Jul 3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus and Atrial Fibrillation (AF), run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 3 Jun 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrence (time frame: six month). 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 NCT06951737, which also lists 1 linked publication.
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 3 Jun 2025.