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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: Recruiting Phase 3 study of Diabetes Mellitus and Atrial Fibrillation, sponsored by University of Oklahoma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT05174052 shows while recruiting
NCT05174052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05174052's enrollment target sits among peer trials
28 181st of 208 higher than 27 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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