Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)

Last updated: April 29, 2024
Sponsor: University of Oklahoma
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes And Hypertension

Cardiac Disease

Treatment

Placebo

Dapagliflozin 10Mg Tab

Clinical Study ID

NCT05174052
13694
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with DM
  • Paroxysmal AF

Exclusion

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

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 01, 2022
Estimated Completion Date:
April 01, 2025

Study Description

Patients with diabetes mellitus (DM) and atrial fibrillation (AF) represent a high-risk cohort that is at an increased risk of cardiovascular complications as compared to AF patients without DM. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. However, none of these clinical trials studied AF as a primary outcome. SGLT2i have multiple properties that can be protective against AF and the role of SGLT2i in preventing recurrent AF remains an important knowledge gap.

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.

Connect with a study center

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.