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Study on Preventing Atrial Fibrillation Recurrence After Cardioversion Using Dapagliflozin in Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the condition known as atrial fibrillation, which is a common heart rhythm disorder where the heart beats irregularly and often rapidly. The study is investigating the effects of a treatment using a medication called dapagliflozin. Dapagliflozin is a chemical substance that is taken orally and is being compared to the usual care provided to patients with atrial fibrillation.

The purpose of the study is to determine if treatment with dapagliflozin can extend the time before atrial fibrillation returns within 30 days after a procedure called cardioversion. Cardioversion is a medical procedure used to restore a normal heart rhythm in people with certain types of abnormal heartbeats. Participants in the study will be randomly assigned to receive either dapagliflozin or the usual care. The study will monitor the recurrence of atrial fibrillation and other related outcomes over a period of 30 days following cardioversion.

Throughout the study, researchers will observe various factors, such as the proportion of patients who maintain a normal heart rhythm 30 days after cardioversion and the total number of days with atrial fibrillation recordings during this period. The study aims to provide valuable insights into whether dapagliflozin can be an effective treatment option for managing atrial fibrillation after cardioversion.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing written consent. Eligibility includes being 55 years or older and having atrial fibrillation (AF) on an electrocardiogram (ECG).
The plan is for electrical cardioversion, a procedure to restore normal heart rhythm, to occur within 7 to 26 days from the inclusion date.
Step 2
Randomization and treatment
Participants are randomly assigned to receive either dapagliflozin or usual care. Dapagliflozin is taken orally.
The objective is to assess if dapagliflozin prolongs the time to AF recurrence within 30 days after cardioversion.
Step 3
Cardioversion procedure
Electrical cardioversion is performed to attempt to restore normal heart rhythm.
The success of the procedure is measured by discharge with sinus rhythm (SR), which is a normal heart rhythm.
Step 4
Follow-up period
The primary endpoint is the time to recurrence of AF within 30 days after cardioversion.
Secondary endpoints include the proportion of patients in SR 30 days after cardioversion, the proportion without any AF recurrence at 30 days, and the total number of days with AF recordings during the 30 days following cardioversion.
Step 5
Completion of study
The study is estimated to end by December 31, 2027.
The results will help determine the effectiveness of dapagliflozin in preventing AF recurrence compared to usual care.

Who can join the trial?

4 criteria

Patients must have **atrial fibrillation (AF)**, which is a type of irregular heartbeat, shown on an **ECG** (a test that records the electrical activity of the heart).
Patients should be scheduled for **electrical cardioversion**, a procedure to restore a normal heart rhythm, within 7 to 26 days from the date they join the study.
Patients must be **55 years old or older**.
Patients need to provide their **written consent** to participate in the study, meaning they agree to join after understanding what the study involves.

Who cannot join the trial?

10 criteria

Patients who have a history of severe allergic reactions to the study medication.
Patients with severe kidney problems, as the medication may not be safe for them.
Patients with severe liver problems, which could affect how the medication works in the body.
Patients who are pregnant or breastfeeding, to avoid any potential risks to the baby.
Patients who are currently participating in another clinical trial, to prevent interference with study results.
Patients with certain heart conditions that are not stable, as this could increase health risks.
Patients who have had a recent heart attack, as this could complicate their health condition.
Patients with uncontrolled high blood pressure, which could pose additional health risks.
Patients with a history of drug or alcohol abuse, which could affect their ability to follow the study requirements.
Patients who are unable to give informed consent, meaning they cannot fully understand and agree to the study details.

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Verified sites

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Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden
Soedersjukhuset AB
Responsive
Stockholm, Sweden

Trial locations

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Investigated drugs

Dapagliflozin is a medication used in this trial to see if it can help delay the return of atrial fibrillation, a type of irregular heartbeat, after a procedure called cardioversion. Cardioversion is a treatment that helps restore a normal heart rhythm. Dapagliflozin is typically used to manage blood sugar levels in people with diabetes, but in this study, researchers are exploring its potential benefits for heart rhythm issues.

Dapagliflozin Propanediol

What is already known about the treatment

Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied in clinical trials for its potential to prevent the recurrence of atrial fibrillation after cardioversion. The main therapeutic indication being explored is its ability to prolong the time before atrial fibrillation returns. At the molecular level, dapagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which helps reduce blood sugar levels and may have beneficial effects on heart rhythm. It is classified as an SGLT2 inhibitor, primarily used for managing type 2 diabetes, but its role in heart conditions is under investigation.

Investigated diseases

Atrial fibrillation – Atrial fibrillation is a common heart rhythm disorder where the heart's upper chambers (atria) beat irregularly and often rapidly. This irregular rhythm can lead to poor blood flow and may cause symptoms like palpitations, fatigue, and shortness of breath. The condition can vary in duration, with some episodes lasting minutes and others persisting for days or longer. Over time, atrial fibrillation can become more frequent and persistent. It can also lead to complications such as blood clots forming in the heart, which can travel to other parts of the body. Managing atrial fibrillation often involves addressing the underlying causes and monitoring the heart's rhythm.