RecruitingPhase 3NCT05174052

Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)

Dapagliflozin in Patients With Atrial Fibrillation


Sponsor

University of Oklahoma

Enrollment

28 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether dapagliflozin, a diabetes medication also used for heart protection, can benefit people who have both Type 2 diabetes and a type of irregular heartbeat called paroxysmal atrial fibrillation (AF), where the heart rhythm comes and goes. **You may be eligible if:** - You have been diagnosed with Type 2 diabetes - You have paroxysmal atrial fibrillation (episodes of irregular heartbeat that start and stop on their own) **You may NOT be eligible if:** - You have Type 1 diabetes - You have low blood pressure (systolic below 90 mmHg) - You have severe kidney disease - You have had a lower limb amputation - You are allergic to dapagliflozin - You are already taking an SGLT2 inhibitor medication - You are pregnant - You are currently taking anti-arrhythmia drugs - You are scheduled for catheter ablation to treat your heart rhythm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin 10Mg Tab

Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.

DRUGPlacebo

Subjects will take 1 blinded capsule of placebo drug dosed once daily


Locations(1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

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NCT05174052


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