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Dapagliflozin for Atrial Fibrillation

Phase 3

Recruiting

Led By Zain Ul Abideen Asad, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with DM

Paroxysmal AF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months

Awards & highlights

Pivotal Trial

Summary

This trial will research if a diabetes medication can help lower atrial fibrillation burden & improve quality of life in DM patients with AF. Measurements will be taken at baseline & end of study.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of Dapagliflozin may include yeast infections, urinary tract infections, increased urination, sore throat and runny nose. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with diabetes.

Select...

I have episodes of irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The effect of Dapagliflozin on change in burden of atrial fibrillation

Secondary study objectives

Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey

Other study objectives

Effect of Dapagliflozin on change in Validated Echocardiographic Indices & Biomarkers of Atrial Myopathy

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intervention Arm (Dapagliflozin)Active Control1 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 Group1 Intervention

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

0 / 2Eligibility criteria met