Effect of Dapagliflozin on Atrial Fibrillation in Diabetic Patients
Dapagliflozin in Patients With Atrial Fibrillation
This study is testing if the diabetes medication Dapagliflozin can help reduce the heart rhythm problems caused by atrial fibrillation in people with diabetes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05174052 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Dapagliflozin on the burden of atrial fibrillation (AF) in patients with diabetes mellitus (DM). Participants diagnosed with paroxysmal AF and DM will be randomized to receive either Dapagliflozin or a placebo. The primary outcome will be measured through continuous heart rhythm monitoring over a two-week period, along with assessments of quality of life and echocardiographic indices. The goal is to explore the therapeutic potential of SGLT2 inhibitors in reducing AF burden and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with diabetes mellitus and paroxysmal atrial fibrillation.
Not a fit: Patients with type 1 diabetes, severe renal impairment, or those currently taking anti-arrhythmic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with diabetes and atrial fibrillation, potentially reducing AF burden and improving quality of life.
How similar studies have performed: While SGLT2 inhibitors have shown cardiovascular benefits in other studies, this specific approach to atrial fibrillation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Zain Ul Abideen Asad, MD — University of Oklahoma
- Study coordinator: Aurora Vera
- Email: Aurora-Vera@ouhsc.edu
- Phone: 405-271-8001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.