Phase 4 N=25 Randomized Quadruple-blind Treatment

Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT04792190 ↗

Enrolled (actual)

Serious AEs

8.0%

Results posted

Dec 2024

Primary outcome: Primary: Mean Percentage of Time Spent in Atrial Fibrillation — 2.74; 5.85 percentage of time

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: dapagliflozin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percentage of Time Spent in Atrial Fibrillation	2.74; 5.85	—
SECONDARY Rate of Health Care Utilization	132; 104	—
SECONDARY Percentage of Participants Hospitalized for Heart Failure Post Catheter Ablation of AF	0; 0	—
SECONDARY Mean Quality of Life Score Using the QualiTy-of-life (AFEQT) Questionnaire	20.7; 15.4	—

Summary

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of atrial fibrillation (AF) on the burden of AF during 6-12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 25 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients.

Eligibility Criteria

Inclusion Criteria

Eligible for treatment with dapagliflozin per current FDA-approved indications, including: 1) heart failure (NYHA class II-IV) with reduced left ventricular ejection fraction ( 18 years
Existing functional CIED or planned to undergo CIED implant as SOC before or within 24 hours following the AF ablation procedure and prior to randomization date.

Exclusion Criteria

Type 1 diabetes mellitus
History of diabetic keto-acidosis
Child Pugh Class C liver disease
Last measured estimated GFR < 25 ml/minute/1.73 m2
Pregnancy, plan to become pregnant <1 year after consent or breast feeding
Current therapy with an SGLT2 inhibitor
Hypersensitivity to dapagliflozin
On heart transplant list or likely to undergo heart transplant
Unwilling or unable to cooperate with the protocol
Participation in other clinical trials (observational registries are allowed with approval).
Unwilling to sign the consent for participation
Life expectancy <1 year after consent date for any medical condition

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04792190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.