Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
28 (estimated)
Sponsor
University of Oklahoma · Other
Who this trial is looking for
This trial is looking for people with diabetes and paroxysmal atrial fibrillation. Participants will take either Dapagliflozin or a placebo and will have their heart rhythm monitored over three months to see how the treatment affects their condition and quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with diabetes.
I have paroxysmal atrial fibrillation.
You may not be able to join if
I have type 1 diabetes.
I have symptoms of low blood pressure.
I have severe kidney problems.
I have had a lower limb amputation.
I am allergic to Dapagliflozin.
I am currently taking any SGLT2 inhibitors.
I am pregnant.
I am currently taking anti-arrhythmic drugs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 p…
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.
Trial Locations
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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 tak…
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
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