Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT05174052
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10Mg Tab — DRUG
    Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.
  • Placebo — DRUG
    Subjects will take 1 blinded capsule of placebo drug dosed once daily

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control Arm (Placebo)
    Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme.
  • Active Comparator: 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

Primary Outcome Measure

The effect of Dapagliflozin on change in burden of atrial fibrillation [ Time Frame: Baseline and 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Antwanya Shaw
[email protected]
405-271-9060
Zain Asad, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Oklahoma City, OK

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OK

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