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Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Apr 1, 2025 to Apr 2027
    • Study completion date: Apr 1, 2025 to Dec 2027
    v5
  2. Primary and study completion dates: Apr 1, 2024 to Apr 1, 2025v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 1, 2022 to Apr 1, 2024
    • Site details revised
    v3
  4. Primary and study completion dates: Oct 2023 to Sep 1, 2022
    • Start date: Feb 2022 to Jun 1, 2022
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Oklahoma
162 trials monitored
See 9 trials at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Atrial Fibrillation
1,182 trials monitored
See 50 trials at risk
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.
Trial Details
NCT Number NCT05174052
Lead Sponsor University of Oklahoma
Conditions
(from sponsor)		 Diabetes Mellitus, Atrial Fibrillation
Related terms Atrial Fibrillation, Diabetes Mellitus
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov