Overview

Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)

Status:
Not yet recruiting

Trial end date:
2023-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Oklahoma

Treatments:

Dapagliflozin

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 taking any SGLT2i,

- Pregnancy,

- Currently taking anti-arrhythmic drugs

- Undergoing catheter ablation will be excluded