28 Participants Needed

Dapagliflozin for Atrial Fibrillation

MS
AS
AV
NW
Overseen ByNatalia Wells-Serrano
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will investigate the effect of Dapagliflozin on atrial fibrillation (AF) burden. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous heart rhythm monitoring at baseline and at 3 months, quality of life (QOL) and validated echocardiographic indices of atrial myopathy. This knowledge will enable us to study the therapeutic potential of SGLT2i as a novel adjunct treatment for patients with DM and AF. Patients with paroxysmal AF (AF that terminates spontaneously or with intervention within seven days of onset) and DM and randomize them to Dapagliflozin or placebo. Continuous heart rhythm monitoring patch for AF burden will be used, measure of QOL with the help of AF Effect on Quality-of-life survey and perform an echocardiogram with measurement of left atrial volume index, left atrial strain and atrial tissue dopplers. All measurements will be performed at baseline and at study completion. The central hypothesis is that SGLT2i will lead to reduced AF burden that will translate into improvement in QOL, and the underlying mechanism is improvement in atrial myopathy.

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 dapagliflozin safe for humans?

Dapagliflozin, also known as Farxiga or Forxiga, is generally well-tolerated and has a consistent safety profile across various conditions, including type 2 diabetes and heart failure. It has been approved for reducing risks related to kidney and heart issues, and its safety has been evaluated in multiple studies.12345

What data supports the effectiveness of the drug Dapagliflozin for atrial fibrillation?

Dapagliflozin is known to help reduce the risk of heart-related issues and kidney problems in people with chronic kidney disease and type 2 diabetes, which suggests it might have benefits for heart health. However, there is no direct evidence from the provided research specifically supporting its effectiveness for atrial fibrillation.12356

Who Is on the Research Team?

ZU

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?
2Treatment groups
Active Control
Placebo Group
Group I: Intervention Arm (Dapagliflozin)Active Control1 Intervention
Group II: Control Arm (Placebo)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Published Research Related to This Trial

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.
Antidiabetic Drug Approved to Reduce Risk of Kidney Disease.Aschenbrenner, DS.[2023]
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.
Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes.Maranghi, M., Carnovale, A., Durante, C., et al.[2021]
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.
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]

Citations

Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. [2023]
Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. [2021]
Dapagliflozin/Saxagliptin Fixed-Dose Tablets: A New Sodium-Glucose Cotransporter 2 and Dipeptidyl Peptidase 4 Combination for the Treatment of Type 2 Diabetes. [2022]
[Dapagliflozin (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes]. [2021]
Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. [2021]
Dapagliflozin: A Review in Symptomatic Heart Failure with Reduced Ejection Fraction. [2022]
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