Recruiting
Phase 3

Dapagliflozin

Sponsor:

University of Oklahoma

Code:

NCT05174052

Conditions

Diabetes Mellitus

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dapagliflozin 10Mg Tab

Placebo

Study Details

Brief 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

Diabetes Mellitus

Atrial Fibrillation

Study ID

NCT05174052

Start date

Jun 1, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed with DM
  • Paroxysmal AF

Exclusion Criteria:

  • 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,
  • Pregnancy,
  • Currently taking anti-arrhythmic drugs
  • Undergoing catheter ablation will be excluded

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control Arm (Placebo)

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

active comparator: Intervention Arm (Dapagliflozin)

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

Interventions

Dapagliflozin 10Mg Tab

Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.

Placebo

Subjects will take 1 blinded capsule of placebo drug dosed once daily

Primary outcome measure

  • The effect of Dapagliflozin on change in burden of atrial fibrillation [ Time Frame: Baseline and 3 months ]

Central Contacts and Locations

Central contacts

Aurora Vera

405-271-8001Aurora-Vera@ouhsc.edu

Natalia Wells-Serrano

405-271-4742natalia-wellsserrano@ouhsc.edu

Locations

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Antwanya Shaw

405-271-9060Antwanya-Shaw-1@ouhsc.edu

Principal Investigator:

Zain Asad, MD

More Information

Sponsor

University of Oklahoma

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-04-01.