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Intervention Arm (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

Study 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.Check my eligibility
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.See study design
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.
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I have episodes of irregular heartbeat.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The effect of Dapagliflozin on change in burden of atrial fibrillation
Secondary outcome measures
Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey
Other outcome measures
Effect of Dapagliflozin on change in Validated Echocardiographic Indices & Biomarkers of Atrial Myopathy

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.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,582 Total Patients Enrolled
13 Trials studying Atrial Fibrillation
2,650 Patients Enrolled for Atrial Fibrillation
Zain Ul Abideen Asad, MDPrincipal InvestigatorUniversity of Oklahoma
1 Previous Clinical Trials
34 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
2022. "Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05174052.
~10 spots leftby Apr 2025
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