Diabetes MellitusPhase 3NCT05174052
Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
A Phase 3 study testing Dapagliflozin 10Mg Tab in people with Diabetes Mellitus and Atrial Fibrillation, run by University of Oklahoma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Atrial Fibrillation
- What is being tested?
- Dapagliflozin 10Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with DM
- Paroxysmal AF
Who cannot join
- Type 1 DM,
- Symptoms of hypotension or systolic blood pressure <90mmHg,
- Severe renal impairment with eGFR<30mL/minute/1.73m2,
- History of lower limb amputation,
- Hypersensitivity to Dapagliflozin,
- Currently taking any SGLT2i,
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- Pregnancy,
- Currently taking anti-arrhythmic drugs
- Undergoing catheter ablation will be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Antwanya Shaw, 405-271-9060, Antwanya-Shaw-1@ouhsc.edu
Zain Asad, MD
About this study
Official title: Dapagliflozin in Patients With Atrial Fibrillation
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.
Read the detailed description
Patients with diabetes mellitus (DM) and atrial fibrillation (AF) represent a high-risk cohort that is at an increased risk of cardiovascular complications as compared to AF patients without DM. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. However, none of these clinical trials studied AF as a primary outcome. SGLT2i have multiple properties that can be protective against AF and the role of SGLT2i in preventing recurrent AF remains an important knowledge gap.
In this translational research proposal, we aim to fill this knowledge gap by studying the effect of Dapagliflozin on 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 will be enrolled. Subjects will be randomized to Dapagliflozin or placebo. Continuous heart rhythm monitoring patch for AF burden, measure 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. Our 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
- Diabetes Mellitus, Atrial Fibrillation
- Being tested
- Dapagliflozin 10Mg Tab, Placebo
- Medical subject headings
- Diabetes Mellitus, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.
PlaceboDrug
Subjects will take 1 blinded capsule of placebo drug dosed once daily
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (Placebo) | Placebo comparator | Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme. Receives: Drug: Placebo |
| Intervention Arm (Dapagliflozin) | Active comparator | 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 Receives: Drug: Dapagliflozin 10Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Dapagliflozin on change in burden of atrial fibrillation
To determine the effect of Dapagliflozin on change in AF burden in patients with AF and DM. 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. The AF burden between Dapagliflozin vs Placebo will be compared.
Measured: Baseline and 3 months
Secondary outcomes (1)
Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey
To determine the effect of Dapagliflozin on change in quality of life in patients with AF and DM. AF Effect on Quality of Life Survey will be used to compare QOL between Dapagliflozin vs Placebo.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Jun 2022
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double blind, placebo-controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zain Ul Abideen Asad, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174052
- Sponsor's protocol ID
- 13694
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2021
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05174052
- Acronym / sponsor ID
- 13694
- Conditions
- Diabetes Mellitus, Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with diabetes mellitus (DM) and atrial fibrillation (AF) represent a high-risk cohort that is at an increased risk of cardiovascular complications as compared to AF patients without DM. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. However, none of these clinical trials studied AF as a primary outcome. SGLT2i have multiple properties that can be protective against AF and the role of SGLT2i in preventing recurrent AF remains an important knowledge gap.
In this translational research proposal, we aim to fill this knowledge gap by studying the effect of Dapagliflozin on 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 will be enrolled. Subjects will be randomized to Dapagliflozin or placebo. Continuous heart rhythm monitoring patch for AF burden, measure 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. Our 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double blind, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Control Arm (Placebo) | Placebo comparator | Drug: PlaceboSubjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme. |
| Intervention Arm (Dapagliflozin) | Active comparator | Drug: Dapagliflozin 10Mg TabA 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with DM
- Paroxysmal AF
Key exclusion criteria (9 listed)
- Type 1 DM,
- Symptoms of hypotension or systolic blood pressure <90mmHg,
- Severe renal impairment with eGFR<30mL/minute/1.73m2,
- History of lower limb amputation,
- Hypersensitivity to Dapagliflozin,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10Mg TabSubjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily. | Drug | Intervention Arm (Dapagliflozin) |
| PlaceboSubjects will take 1 blinded capsule of placebo drug dosed once daily | Drug | Control Arm (Placebo) |
Primary outcome
The effect of Dapagliflozin on change in burden of atrial fibrillation
Time frame: Baseline and 3 months
To determine the effect of Dapagliflozin on change in AF burden in patients with AF and DM. 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. The AF burden between Dapagliflozin vs Placebo will be compared.
1 secondary outcome
Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zain Ul Abideen Asad, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10Mg Tab in people with Diabetes Mellitus and Atrial Fibrillation, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurora Vera (405-271-8001 ext. 45319, Aurora-Vera@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of Dapagliflozin on change in burden of atrial fibrillation (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.