Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)

NCT05174052 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 13694
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey

  Baseline and 3 months

Other Outcomes (1)

• Effect of Dapagliflozin on change in Validated Echocardiographic Indices & Biomarkers of Atrial Myopathy

  Baseline and 3 months

Study Arms (2)

Control Arm (Placebo)

PLACEBO COMPARATOR

Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme.

Drug: Placebo

Intervention Arm (Dapagliflozin)

ACTIVE COMPARATOR

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

Interventions

Dapagliflozin 10Mg Tab DRUG

Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.

Intervention Arm (Dapagliflozin)

Placebo DRUG

Subjects will take 1 blinded capsule of placebo drug dosed once daily

Control Arm (Placebo)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with DM
• Paroxysmal AF

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Atrial Fibrillation

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zain Ul Abideen Asad, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurora Vera

CONTACT

405-271-8001; Aurora-Vera@ouhsc.edu

Natalia Wells-Serrano

CONTACT

405-271-4742; natalia-wellsserrano@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double blind, placebo-controlled trial.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: December 30, 2021
• Study Start: June 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)