RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Dapagliflozin or Usual Care

NCT07187570 | Recruiting Phase 3 DMC

• 2 other identifiers: EU CT 2024-513719-28-002024-513719-28-00
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this clinical trial is to learn if drug dapagliflozin, a sodium-glucose transport-2 inhibitor, works to treat atrial fibrillation in adults. The main question it aims to answer is:

• Does the drug dapagliflozin reduce the recurrence rate of atrial fibrillation? Researchers will compare drug dapagliflozin to standard therapy to see if drug dapagliflozin reduce the recurrence of atrial fibrillation. Persons with atrial fibrillation who are planned for an electric cardioversion will:
• Take the drug dapagliflozin, or no drug, once a day for a maximum of 56 days
• Undergo a planned electric cardioversion of the atrial fibrillation
• Record the rhythm with a hand-held device that transmits the signal to researchers during the study period, but no longer than for 56 days

Conditions

Atrial Fibrillation (AF)

Keywords

dapagliflozin; sodium-glucose transport-2 inhibitor; electric cardioversion; hand-held ECG device

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation recurrence

  Time to first AF recurrence detected with an ECG- monitoring device within 30 days after planned elective electrical cardioversion.

  30 days after elective electrical cardioversion

Secondary Outcomes (7)

• Proportion of patients in SR at 30 days

  30 days after elective electrical cardioversion

• Proportion of patients without any atrial fibrillation recurrence at 30 days

  30 days after elective electrical cardioversion

• Time to spontaneous return to sinus rhythm before electrical cardioversion

  Up to 26 days

• Spontaneous return to sinus rhythm before cardioversion.

  Up to 26 days

• Success of cardioversion

  Periprocedural

Study Arms (2)

Usual care

NO INTERVENTION

Standard of care

Dapagliflozin

EXPERIMENTAL

Tablet Dapagliflozin 10 mg once daily

Drug: Dapagliflozin 10 mg once daily

Interventions

Dapagliflozin 10 mg once daily DRUG

Tablet Dapagliflozin 10 mg orally during from randomization for maximum 56 days.

Dapagliflozin

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 55 years.
• Provided written informed consent.

You may not qualify if:

• Current treatment with an SGLT2 inhibitor.
• Prior/current diagnosis of heart failure.
• Type 1 diabetes mellitus.
• Estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73m2.
• Pulmonary vein isolation within preceding 3 months or planned pulmonary vein isolation during the study period (56 days).
• Contraindications to SGLT2 inhibitors.
• Any condition or circumstance in which the patient should not participate in the study according to the study investigator.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (7)

Linköping university hosptial

Linköping, 58225, Sweden

NOT YET RECRUITING

Örebro University hospital

Örebro, 70382, Sweden

RECRUITING

Södersjukhuset

Stockholm, 11861, Sweden

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, 14186, Sweden

RECRUITING

Danderyds Hospital

Stockholm, 18527, Sweden

NOT YET RECRUITING

Norrlands universitetssjukhus

Umeå, 90185, Sweden

NOT YET RECRUITING

Akademiska sjukhuset

Uppsala, 75389, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karolina Szummer, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Ziad Hijazi, MD PhD

  Dept. of Medical Sciences, Uppsala University, Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Szummer, MD PhD

CONTACT

+4681238000; karolina.szummer@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective randomized open blinded end-point (PROBE) study

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: September 23, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (7)