Effects of sodium glucose co-transporter-2 inhibitor on atrial arrhythmia burden in patient with cardiovascular implantable electronic device: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210315003

Enrollment

166

Registered

2021-03-15

Start date

2021-03-16

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation in patients with cardiac implantable electronic device Atrial fibrillation in patients with cardiac implantable electronic device

Interventions

Doses of dapagliflozin will be 10 mg daily. At 3 months, dapagliflozin will be discontinued. ,Placebo tablet will have size, shape, and color similar to dapagliflozin 10mg and will be given daily. At

Experimental Drug,Placebo Comparator Drug

dapagliflozin,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Presence of dual chamber CIED (pacemaker or defibrillator) for at least 3 months, 2. Age > 18 years old, 3. Atrial high rate episode (AHRE) with atrial rate >170 beats per minute of more than 6 minutes, 4. Given informed consent

Exclusion criteria

Exclusion criteria: 1. Currently taking SGLT2i, 2. Permanent AF or long-standing persistent AF, 3. Estimated GFR <25 mL/min/1.73 m2, 4. Pregnant or lactation, 5. SBP <95mmHg or symptoms of hypotension, 6. Hospitalized, ACS, CABG, PCI, or cardioversion within 3 months, 7. Atrial arrhythmia ablation within previous 3 months or currently plan, 8. Bladder cancer, 9. History of genital infection within 3 months, 10. History of frequent urinary tract infection (UTI) (>=2 UTI in 6 months or >=3 UTI in 12 months), 11. DM type 1

Design outcomes

Primary

Measure	Time frame
Longest atrial tachycardia/atrial fibrillation episode baseline, 3 months Minutes	—

Secondary

Measure	Time frame
Time in atrial tachycardia/atrial fibrillation baseline, 3 months Percentage,Number of atrial tachycardia/atrial fibrillation baseline, 3 months episodes,Cardiovascular hospitalization 3 months times,All-cause hospitalization 3 months times,New York Heart Association functional class baseline, 3 months symptoms,modified European Heart Rhythm Association score baseline, 3 months atrial fibrillation symptoms,Norepinephrine level baseline, 3 months pg/ml,beta-hydroxybutyrate baseline, 3 months mg/dl,NOD-like receptor family pyrin domain-containing 3 (NLRP3) baseline, 3 months ng/ml,Interleukin-1 beta baseline, 3 months pg/ml,Interleukin-6 baseline, 3 months pg/ml,Interleukin-10 baseline, 3 months pg/ml,Cellular oxidative stress baseline, 3 months Dichlorohydro-Fluorescein Diacetate dye intensity,Superoxide dismutase baseline, 3 months units/ml,Malondialdehyde baseline, 3 months nmol/ml,Mitochondrial respiration baseline, 3 months Seahorse,Dynamin-related protein 1 baseline, 3 months Western blot analysis,Mitofusin 1/2 baseline, 3 months Western blot analysis,OPA1 baseline, 3 months Western blot analysis,AMP-activated protein kinase baseline, 3 months Western blot analysis,Caspase-3 baseline, 3 months Western blot analysis,Peroxisome proliferator-activated receptor-gamma coactivator- 1alpha baseline, 3 months Western blot analysis,Transforming growth factor-beta baseline, 3 months Western blot analysis,Mitochondrial ROS levels baseline, 3 months MitoSOX,Mitochondrial mass baseline, 3 months Mitotracker	—

Measure

Time frame

Time in atrial tachycardia/atrial fibrillation baseline, 3 months Percentage,Number of atrial tachycardia/atrial fibrillation baseline, 3 months episodes,Cardiovascular hospitalization 3 months times,All-cause hospitalization 3 months times,New York Heart Association functional class baseline, 3 months symptoms,modified European Heart Rhythm Association score baseline, 3 months atrial fibrillation symptoms,Norepinephrine level baseline, 3 months pg/ml,beta-hydroxybutyrate baseline, 3 months mg/dl,NOD-like receptor family pyrin domain-containing 3 (NLRP3) baseline, 3 months ng/ml,Interleukin-1 beta baseline, 3 months pg/ml,Interleukin-6 baseline, 3 months pg/ml,Interleukin-10 baseline, 3 months pg/ml,Cellular oxidative stress baseline, 3 months Dichlorohydro-Fluorescein Diacetate dye intensity,Superoxide dismutase baseline, 3 months units/ml,Malondialdehyde baseline, 3 months nmol/ml,Mitochondrial respiration baseline, 3 months Seahorse,Dynamin-related protein 1 baseline, 3 months Western blot analysis,Mitofusin 1/2 baseline, 3 months Western blot analysis,OPA1 baseline, 3 months Western blot analysis,AMP-activated protein kinase baseline, 3 months Western blot analysis,Caspase-3 baseline, 3 months Western blot analysis,Peroxisome proliferator-activated receptor-gamma coactivator- 1alpha baseline, 3 months Western blot analysis,Transforming growth factor-beta baseline, 3 months Western blot analysis,Mitochondrial ROS levels baseline, 3 months MitoSOX,Mitochondrial mass baseline, 3 months Mitotracker

—

Countries

Thailand

Contacts

Public ContactTeerapat Nantsupawat

Chiang Mai University

teerapat.nant@cmu.ac.th6653936713

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026