Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)

Dapagliflozin in Patients With Atrial Fibrillation

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Atrial Fibrillation
• Intervention / Treatment: Drug: Placebo; Drug: Dapagliflozin 10Mg Tab

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Aurora Vera; Phone Number: 45319 405-271-8001; Email: Aurora-Vera@ouhsc.edu
• Study Contact Backup: Name: Natalia Wells-Serrano; Phone Number: 405-271-4742; Email: natalia-wellsserrano@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • University of Oklahoma Health Sciences Center
      • Contact: Antwanya Shaw; Phone Number: 405-271-9060; Email: Antwanya-Shaw-1@ouhsc.edu
      • Principal Investigator: Zain Asad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm (Placebo); Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme.	Drug: Placebo; Subjects will take 1 blinded capsule of placebo drug dosed once daily
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	Drug: Dapagliflozin 10Mg Tab; Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of Dapagliflozin on change in burden of atrial fibrillation	To determine the effect of Dapagliflozin on change in AF burden in patients with AF and DM. 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. The AF burden between Dapagliflozin vs Placebo will be compared.	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey	To determine the effect of Dapagliflozin on change in quality of life in patients with AF and DM. AF Effect on Quality of Life Survey will be used to compare QOL between Dapagliflozin vs Placebo.	Baseline and 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Dapagliflozin on change in Validated Echocardiographic Indices & Biomarkers of Atrial Myopathy	To determine the effect of Dapagliflozin on validated echocardiographic indices and biomarkers of atrial myopathy in patients with AF and DM. We will compare left atrial volume index (ml/m2), left atrial strain and atrial tissue dopplers (cm/s). All measurements will be performed at baseline and at study completion and compared between Dapagliflozin vs Placebo. We will measure brain natriuretic peptide and other biomarkers as well.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Zain Ul Abideen Asad, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Metabolic Diseases; Arrhythmias, Cardiac; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus; Atrial Fibrillation; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; dapagliflozin
• Other Study ID Numbers: 13694

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes