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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2027-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized open blinded end-point (PROBE) study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Dapagliflozin

Tablet Dapagliflozin 10 mg once daily

Group Type EXPERIMENTAL

Dapagliflozin 10 mg once daily

Intervention Type DRUG

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

Interventions

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Dapagliflozin 10 mg once daily

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karolina Szummer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Ziad Hijazi, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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