Dapagliflozin for Atrial Fibrillation

Overseen By Natalia Wells-Serrano

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Oklahoma

Must not be taking: SGLT2i, Anti-arrhythmics

Disqualifiers: Type 1 DM, Severe renal impairment, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

28 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 5 6}

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

I have been diagnosed with diabetes.

I have episodes of irregular heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Dapagliflozin or placebo, with continuous heart rhythm monitoring and quality of life assessments

12 weeks

Baseline and study completion visits

Follow-up

Participants are monitored for changes in AF burden, echocardiographic indices, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dapagliflozin

Trial Overview

The study tests if Dapagliflozin, a diabetes medication, can reduce the amount of time patients spend in AF compared to a placebo. It also looks at quality of life improvements and changes in heart structure/function using continuous monitoring and echocardiograms before and after three months.

How Is the Trial Designed?

Group I: Intervention Arm (Dapagliflozin) Active Control 1 Intervention

A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme

Group II: Control Arm (Placebo) Placebo Group 1 Intervention

Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

The fixed-dose combination of dapagliflozin and saxagliptin (QTERN) effectively reduces hemoglobin A1C levels in patients with uncontrolled type 2 diabetes when used alongside metformin, showing a significant difference in A1C reduction compared to other combinations.

QTERN is generally well tolerated, but its use may be limited by cost and modest efficacy in A1C reduction, highlighting the need for further research on its long-term effects on diabetes complications and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin/Saxagliptin Fixed-Dose Tablets: A New Sodium-Glucose Cotransporter 2 and Dipeptidyl Peptidase 4 Combination for the Treatment of Type 2 Diabetes. Coppenrath, VA., Hydery, T.[2022]

Dapagliflozin effectively lowers blood sugar levels and glycated hemoglobin (HbA1c) in patients with type 2 diabetes, with a low risk of hypoglycemia and additional benefits like weight loss and reduced blood pressure.

While it is generally safe, dapagliflozin can increase the risk of genital infections, particularly in women, and its efficacy may be reduced in patients with kidney issues; ongoing trials are investigating its potential cardiovascular and renal protective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dapagliflozin (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes]. Scheen, AJ.[2021]

Dapagliflozin (Farxiga) is approved for reducing the risk of declining kidney function and kidney failure in adults with chronic kidney disease, regardless of whether they have type 2 diabetes.

It also helps lower the risk of cardiovascular death and hospitalization for heart failure, highlighting its efficacy in managing both kidney and heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. Aschenbrenner, DS.[2023]

Dapagliflozin, an SGLT2 inhibitor, has been shown to significantly reduce the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF), regardless of whether they have type 2 diabetes.

In the DAPA-HF trial, dapagliflozin was well tolerated and demonstrated a lower risk of worsening heart failure or cardiovascular death compared to placebo, making it a valuable treatment option for adults with symptomatic HFrEF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Review in Symptomatic Heart Failure with Reduced Ejection Fraction. Blair, HA.[2022]

Dapagliflozin is an effective treatment for type 2 diabetes, proven through multiple controlled clinical trials that assess its efficacy, safety, and tolerability.

It is approved by the FDA for use as a standalone therapy or in combination with other glucose-lowering medications, including insulin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. Davis, PN., Ndefo, UA., Oliver, A.[2021]

Dapagliflozin (DAPA) is an effective SGLT2 inhibitor for treating type 2 diabetes, showing favorable pharmacokinetics and pharmacodynamics that help lower blood sugar levels while having beneficial effects on other metabolic risk factors.

While DAPA is generally safe, it carries an increased risk of genital and urinary infections, and concerns about bladder cancer and cardiovascular safety remain, prompting the FDA to seek further data on these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. Maranghi, M., Carnovale, A., Durante, C., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11490073/

The Comparison of the Effectiveness of Dapagliflozin and ...

Notably, dapagliflozin demonstrated superior efficacy in preventing atrial fibrillation compared to empagliflozin.

2.

jacc.org

jacc.org/doi/10.1016/j.jacc.2022.08.718

Atrial Fibrillation and Dapagliflozin Efficacy in Patients With ...

The benefit of dapagliflozin on the primary outcome was consistent across AF types: no AF, HR: 0.89 (95% CI: 0.74-1.08); paroxysmal AF, HR: 0.75 (95% CI: 0.58- ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.044183

Effect of Dapagliflozin on Atrial Fibrillation in Patients With ...

Results: Dapagliflozin reduced the risk of AF/AFL events by 19% (264 versus 325 events; 7.8 versus 9.6 events per 1000 patient-years; ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36041668/

Atrial Fibrillation and Dapagliflozin Efficacy in Patients With ...

The benefit of dapagliflozin on the primary outcome was consistent across AF types: no AF, HR: 0.89 (95% CI: 0.74-1.08); paroxysmal AF, HR: 0.75 ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0735109722065299

Atrial Fibrillation and Dapagliflozin Efficacy in Patients With ...

The benefit of dapagliflozin on the primary outcome was consistent across AF types: no AF, HR: 0.89 (95% CI: 0.74-1.08); paroxysmal AF, HR: 0.75 (95% CI: 0.58- ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34766424/

Dapagliflozin and atrial fibrillation in heart failure with ...

Conclusions: Dapagliflozin, compared with placebo, reduced the risk of worsening HF events, cardiovascular death, and all-cause death, and improved symptoms, in ...