Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
NCT05174052 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2026-04-01
Summary
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.
Conditions
Interventions
- DRUG
-
Dapagliflozin 10Mg Tab
Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.
- DRUG
-
Subjects will take 1 blinded capsule of placebo drug dosed once daily
Sponsors & Collaborators
-
University of Oklahoma
lead OTHER
Principal Investigators
-
Zain Ul Abideen Asad, MD · University of Oklahoma
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-01
- Primary Completion
- 2027-04-30
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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