Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
NCT ID: NCT05174052
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
28 participants
INTERVENTIONAL
2022-06-01
2025-04-01
Brief Summary
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Detailed Description
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In this translational research proposal, we aim to fill this knowledge gap by studying the effect of Dapagliflozin on 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 will be enrolled. Subjects will be randomized to Dapagliflozin or placebo. Continuous heart rhythm monitoring patch for AF burden, measure 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. Our 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control Arm (Placebo)
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme.
Placebo
Subjects will take 1 blinded capsule of placebo drug dosed once daily
Intervention Arm (Dapagliflozin)
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme
Dapagliflozin 10Mg Tab
Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.
Interventions
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Dapagliflozin 10Mg Tab
Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.
Placebo
Subjects will take 1 blinded capsule of placebo drug dosed once daily
Eligibility Criteria
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Inclusion Criteria
* Paroxysmal AF
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Zain Ul Abideen Asad, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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13694
Identifier Type: -
Identifier Source: org_study_id
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