Dapagliflozin for Atrial Fibrillation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Dapagliflozin, a diabetes drug, can reduce the time spent in atrial fibrillation (AF), a heart rhythm issue, for people with diabetes. Participants will receive either Dapagliflozin or a placebo to determine if the drug improves heart health and quality of life. The trial seeks individuals with diabetes and paroxysmal AF, where AF episodes resolve on their own or with assistance within a week. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial requires that you stop taking any anti-arrhythmic drugs before participating. If you are currently taking any SGLT2 inhibitors, you will also need to stop those medications.
Is there any evidence suggesting that Dapagliflozin is likely to be safe for humans?
Research shows that dapagliflozin is generally safe for people. In past studies, it has been linked to a lower risk of atrial fibrillation, an irregular heartbeat. For example, one study found a 19% drop in atrial fibrillation cases among those taking dapagliflozin compared to those who did not.
The FDA has already approved dapagliflozin for treating diabetes and heart failure, indicating its general safety. Some side effects can occur, but they are usually mild, such as increased urination or thirst.
Overall, evidence suggests dapagliflozin is a safe choice for many, but discussing any concerns with a healthcare provider is always important.12345Why do researchers think this study treatment might be promising for atrial fibrillation?
Most treatments for atrial fibrillation focus on controlling heart rate or rhythm and preventing blood clots, often using medications like beta-blockers, calcium channel blockers, or anticoagulants. But dapagliflozin offers something different. Originally used to manage diabetes, dapagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which leads to glucose excretion and may have beneficial effects on heart health. Researchers are excited because dapagliflozin might improve heart function and reduce the risk of heart-related complications in patients with atrial fibrillation, offering a novel approach beyond the typical heart rate or rhythm management.
What evidence suggests that Dapagliflozin might be an effective treatment for atrial fibrillation?
Research has shown that dapagliflozin, which participants in this trial may receive, can help reduce episodes of atrial fibrillation (AF), a type of irregular heartbeat. One study found that people taking dapagliflozin had a 19% lower risk of AF events compared to those not taking the drug, with fewer incidents per 1,000 patient-years. Dapagliflozin proved beneficial for people with different types of AF, including paroxysmal AF, which starts and stops on its own. Another study found that dapagliflozin was more effective at preventing AF than a similar drug, empagliflozin. These findings suggest that dapagliflozin could be a promising option for reducing AF in patients.13456
Who Is on the Research Team?
Zain Ul Abideen Asad, MD
Principal Investigator
University of Oklahoma
Are You a Good Fit for This Trial?
This trial is for people with diabetes (DM) and a type of irregular heartbeat called paroxysmal atrial fibrillation (AF), which stops on its own or with treatment within seven days. Participants will be monitored over time to see how often they have AF episodes.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either Dapagliflozin or placebo, with continuous heart rhythm monitoring and quality of life assessments
Follow-up
Participants are monitored for changes in AF burden, echocardiographic indices, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Dapagliflozin
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor