NCT06433479

Brief Summary

This is a single-center, parallel-group, randomized, open-label trial evaluating the effect of 3-month treatment with dapagliflozin 10mg once daily on the recurrence of atrial fibrillation after catheter ablation for atrial fibrillation in patients without diabetes, heart failure, or chronic kidney disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

May 23, 2024

Last Update Submit

July 13, 2025

Conditions

Atrial Fibrillation

Keywords

Catheter ablationAtrial fibrillationRecurrenceDapagliflozinAF Burden

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation burden at 3 months after ablation

    Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 3 months after ablation.

    3 months

Secondary Outcomes (5)

  • Atrial fibrillation recurrence during 3 months after ablation

    3 months

  • Changes of quality of life at 3 months

    3 months

  • Echocardiography changes of left atrial structure at 3 months

    3 months

  • Atrial fibrillation recurrence during 1 year after ablation

    1 year

  • Cardiovascular outcomes during 1-year follow-up

    1 year

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg per day for 3 months after initial catheter ablation

Drug: Dapagliflozin 10 mg per day for 3 months after initial catheter ablation

Control

NO INTERVENTION

No intervention

Interventions

Dapagliflozin 10 mg per day for 3 months after initial catheter ablationDRUG

Dapagliflozin 10 mg per day for 3 months after initial catheter ablation

Dapagliflozin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18-80 years
  • diagnosed with persistent atrial fibrillation based on ECG or Holter
  • planned initial catheter ablation for atrial fibrillation
  • have the capacity to understand and sign an informed consent form.

You may not qualify if:

  • diagnosed with persistent atrial fibrillation longer than 5 years or left atrial anterior-posterior diameter ≥ 50mm
  • diagnosed with atrial fibrillation secondary to reversible causes (such as hyperthyroidism, acute infection, etc.)
  • severe structural heart disease (hypertrophic cardiomyopathy, rheumatic heart disease, dilated cardiomyopathy, etc.)
  • currently take sodium-glucose co-transporter 2 inhibitors
  • have the following Class I indications for sodium-glucose co-transporter 2 inhibitors: i. type 2 diabetes ii. history of heart failure (HF), including HF with reduced ejection fraction, mildly reduced ejection fraction, and preserved ejection fraction iii. chronic kidney disease with eGFR=20-60 ml/min/1.73m2
  • have the following contraindication of sodium-glucose co-transporter 2 inhibitors: i. previous allergic reactions to dapagliflozin ii. end-stage renal failure or dialysis
  • type 1 diabetes, or previous diabetic ketoacidosis
  • severe hypoglycemia or genitourinary infection in the past 12 months
  • hypovolemia or hypotension
  • planned surgery or other interventional procedure within 3 months
  • other arrhythmias mandating anti-arrhythmic drug therapy
  • have intracardiac thrombus
  • active infection
  • unable to give informed consent
  • women of childbearing potential
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

  • Jiang C, Zhao Z, Yang Z, Wang Y, Xu Y, Xu H, Guo H, Wang C, He L, Xia S, Kong X, Dai W, Zhang J, Zuo S, Liu X, Guo X, Liu N, Li S, Zhou N, Jiang C, Tang R, Sang C, Zei PC, Long D, Du X, Dong J, Macle L, Ma C. Dapagliflozin to Reduce Early Recurrence After Catheter Ablation for Atrial Fibrillation: The DARE-AF Randomized Clinical Trial. Circulation. 2026 Feb 3;153(5):297-306. doi: 10.1161/CIRCULATIONAHA.125.077447. Epub 2025 Nov 9.

    PMID: 41206792DERIVED

MeSH Terms

Conditions

Atrial FibrillationRecurrence

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 29, 2024

Study Start

July 15, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)