Atrial Fibrillation (AF)Phase 3RECUR-AFNCT07187570
RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Dapagliflozin or Usual Care
A Phase 3 study testing Dapagliflozin 10 mg once daily in people with Atrial Fibrillation (AF), run by Region Stockholm at 7 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Dapagliflozin 10 mg once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 7 sitesSweden
- Study dates
- 3 Jun 2025to Dec 2027
- Phase
- Phase 3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AF on ECG who are planned for electrical cardioversion within 7-26 days from inclusion-date.
- Age ≥ 55 years.
- Provided written informed consent.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Sweden7 sites, 7 recruiting
- Not yet recruiting
Linköping university hosptial
Linköping, 58225
Lars O Karlsson, MD PhD, +4610-103 00 00, Lars.O.Karlsson@regionostergotland.se
Lars O Karlsson, MD PhD
- Recruiting
Örebro University hospital
Örebro, 70382
Anna Björkenheim, MD PhD, +46 19-602 10 00, anna.bjorkenheim@regionorebrolan.se
Anna Björkenheim, MD PhD
- Not yet recruiting
Södersjukhuset
Stockholm, 11861
Joakim Olbers, MD PhD, +46 8-123 610 00, joakim.olbers@regionstockholm.se
Joakim Olbers, MD PhD
- Recruiting
Karolinska University Hospital
Stockholm, 14186
Karolina Szummer, MD PhD, +46812386719, karolina.szummer@regionstockholm.se
Karolina Szummer, MD PhD
- Not yet recruiting
Danderyds Hospital
Stockholm, 18527
Johan Engdahl, Professor, MD PhD, +468-123 550 00, johan.engdahl@regionstockholm.se
- Not yet recruiting
Norrlands universitetssjukhus
Umeå, 90185
Ioannis Kotsoularis, MD PhD, +4690-785 00 00, ioannis.katsoularis@umu.se
Ioannis Kotsoularis, MD PhD
- Not yet recruiting
Akademiska sjukhuset
Uppsala, 75389
Ziad Hijazi, MD PhD, +4618-611 00 00, ziad.hijazi@uu.se
Ziad Hijazi, MD PhD
About this study
Official title: RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Open-label Treatment With Dapagliflozin or Usual Care
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?
Read more
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)
- Being tested
- Dapagliflozin 10 mg once daily
- Keywords
- dapagliflozin, sodium-glucose transport-2 inhibitor, electric cardioversion, hand-held ECG device
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 mg once dailyDrug
Tablet Dapagliflozin 10 mg orally during from randomization for maximum 56 days.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Standard of care |
| Dapagliflozin | Experimental | Tablet Dapagliflozin 10 mg once daily Receives: Drug: Dapagliflozin 10 mg once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrence
Time to first AF recurrence detected with an ECG- monitoring device within 30 days after planned elective electrical cardioversion.
Measured: 30 days after elective electrical cardioversion
Secondary outcomes (7)
Proportion of patients in SR at 30 days
Proportion of patients in SR 30 days after cardioversion.
Measured: 30 days after elective electrical cardioversion
Proportion of patients without any atrial fibrillation recurrence at 30 days
Proportion of patients without any atrial fibrillation recurrence at 30 days
Measured: 30 days after elective electrical cardioversion
Time to spontaneous return to sinus rhythm before electrical cardioversion
Time to spontaneous return to sinus rhythm measured from randomization to electrical cardioversion (max 26 days)
Measured: Up to 26 days
Spontaneous return to sinus rhythm before cardioversion.
Number of patients with return to sinus rhythm at time of electrical cardioversion (maximum 26 days from randomization)
Measured: Up to 26 days
Success of cardioversion
Discharged with sinus rhythm after electric cardioversion
Measured: Periprocedural
Total number of days with atrial fibrillation
Total number of days with AF recordings during the 30 days following cardioversion.
Measured: From day of electric cardioversion to 30 days after
Absence of clinical atrial fibrillation recording
Absence of clinical atrial fibrillation recurrence (12-lead ECG-verified) during follow-up after cardioversion or after spontaneous return to SR (before cardioversion).
Measured: From randomization to 30 days after electric cardioversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start3 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized open blinded end-point (PROBE) study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Karolina Szummer, MD PhD, Principal investigator, Karolinska InstitutetZiad Hijazi, MD PhD, Principal investigator, Dept. of Medical Sciences, Uppsala University, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187570
- Sponsor's protocol ID
- EU CT 2024-513719-28-00
- Other IDs
- 2024-513719-28-00
- Acronym
- RECUR-AF
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECURrence of Atrial Fibrillation After Cardioversion of Patients Randomized to Open-label Treatment With Dapagliflozin or Usual Care
- ClinicalTrials.gov ID
- NCT07187570
- Acronym / sponsor ID
- RECUR-AF / EU CT 2024-513719-28-00
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- dapagliflozin, sodium-glucose transport-2 inhibitor, electric cardioversion, hand-held ECG device
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Sep 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized open blinded end-point (PROBE) study
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Standard of care |
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10 mg once dailyTablet Dapagliflozin 10 mg once daily |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with AF on ECG who are planned for electrical cardioversion within 7-26 days from inclusion-date.
- Age ≥ 55 years.
- Provided written informed consent.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 mg once dailyTablet Dapagliflozin 10 mg orally during from randomization for maximum 56 days. | Drug | Dapagliflozin |
Primary outcome
Atrial fibrillation recurrence
Time frame: 30 days after elective electrical cardioversion
Time to first AF recurrence detected with an ECG- monitoring device within 30 days after planned elective electrical cardioversion.
7 secondary outcomes
Proportion of patients in SR at 30 days
Time frame: 30 days after elective electrical cardioversion
Proportion of patients without any atrial fibrillation recurrence at 30 days
Time frame: 30 days after elective electrical cardioversion
Time to spontaneous return to sinus rhythm before electrical cardioversion
Time frame: Up to 26 days
Spontaneous return to sinus rhythm before cardioversion.
Time frame: Up to 26 days
Success of cardioversion
Time frame: Periprocedural
Total number of days with atrial fibrillation
Time frame: From day of electric cardioversion to 30 days after
Absence of clinical atrial fibrillation recording
Time frame: From randomization to 30 days after electric cardioversion
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 23 Sep 2025.
- 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.
Karolina Szummer, MD PhD principal investigator
Karolinska Institutet
Ziad Hijazi, MD PhD principal investigator
Dept. of Medical Sciences, Uppsala University, Uppsala, Sweden
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10 mg once daily in people with Atrial Fibrillation (AF), run by Region Stockholm at 7 sites in Sweden.
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 7 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 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Karolina Szummer, MD PhD (+4681238000, karolina.szummer@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrence (time frame: 30 days after elective electrical cardioversion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2025.