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NCT05174052 · ClinicalTrials.gov registry record · Phase 3
Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
A Phase 3 study of Diabetes Mellitus and Atrial Fibrillation, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05174052 is a Phase 3 study of Diabetes Mellitus and Atrial Fibrillation that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 28 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05174052, a Phase 3 study of Diabetes Mellitus and Atrial Fibrillation, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Dapagliflozin 10Mg Tab
Study Locations (1)
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2025-04-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05174052
The ClinicalTrials.gov registry entry for NCT05174052 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (99% lower). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05174052 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT05174052 about?
NCT05174052 is a clinical study titled "Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)". 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 ec...
What is the current status of trial NCT05174052?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2022-06-01. Estimated completion is 2025-04-01.
What conditions does trial NCT05174052 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Atrial Fibrillation.
What interventions are being tested in trial NCT05174052?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin 10Mg Tab (DRUG).
Who is sponsoring clinical trial NCT05174052?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05174052 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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