NCT06951737

Brief 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. The two groups were monitored for AF recurrence on the first day, then at one, three, and six months after CV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 2, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

April 20, 2025

Last Update Submit

June 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation recurrence

    six month

Study Arms (1)

SGLT-2 inhibitor user

patients with diabetes mellitus, atrial fibrillation and using SGLT-2 inhibitor

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with DM and AF who were planned to undergo electrical cardioversion were evaluated for suitability for the study.

You may qualify if:

  • patients \> 18 years and \< 90 years,
  • Patient diagnosed with DM
  • Patient underwent electrical cardioversion due to AF and was restored to sinus rhythm

You may not qualify if:

  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Hastanesi

Bursa, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes MellitusAtrial Fibrillation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 30, 2025

Study Start

October 2, 2022

Primary Completion

April 2, 2024

Study Completion

October 2, 2024

Last Updated

June 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations