NCT05174052 Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
| NCT ID | NCT05174052 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Oklahoma |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 28 participants in total. It began in 2022-06-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Zain Ul Abideen Asad, MD
PRINCIPAL INVESTIGATOR
University of Oklahoma
Frequently Asked Questions
Who can join the NCT05174052 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05174052 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 28 participants.
Is NCT05174052 currently recruiting?
Yes, NCT05174052 is actively recruiting participants. Contact the research team at Aurora-Vera@ouhsc.edu for enrollment information.
Where is the NCT05174052 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT05174052 clinical trial?
NCT05174052 is sponsored by University of Oklahoma. The principal investigator is Zain Ul Abideen Asad, MD at University of Oklahoma. The trial plans to enroll 28 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.