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The Effect of Dapagliflozin in Patient with Paroxysmal Atrial Fibrillation: A Prospective, Randomized, Blank Controlled, Single-Center Study

The Effect of Dapagliflozin in Patient with Paroxysmal Atrial Fibrillation: A Prospective, Randomized, Blank Controlled, Single-Center Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058691
Enrollment
Unknown
Registered
2022-04-14
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Atrial fibrillation

Interventions

Intervention:Dapagliflozin 10mg/day
Control:No intervention

Sponsors

Affiliated Drum Tower Hospital, Nanjing University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with dual-chamber permanent pacemaker with advanced atrial fibrillation detection algorithms and paroxysmal atrial fibrillation and a device burden between 1 and 50% during the last month were recruited.

Exclusion criteria

Exclusion criteria: 1. Patients with permanent pacemaker without advanced atrial fibrillation detection algorithms; 2. Persistent atrial fibrillation; 3. Heart failure with NYHA function III-IV; 4. Severe valvular disease or have prosthetic valve; 5. Previous treatment with AF ablation or plan to receive ablation within 6 months; 6. Receiving cardiac surgery in the last 3 months, or plan to receive within 6 months; 7. Type 1 DM, or other clinically uncontrolled endocrine disease; 8. Severe kidney dysfunction eGFR3 upper normal limit, or bilirubin > 2 upper normal limit); 10. Acute cardiovascular event [e.g., stroke, TIA, acute coronary syndrome (ACS), revascularization ] < 2 months prior to baseline study; 11. Chronic cystitis and/or recurrent genitourinary tract infections (3 or more in the last year); 12. Previous treatment with any SGLT2 inhibitor in the last month; 13. Previous DKA, Diabetic coma, or frequent Hypoglycemic episode; 14. Malnutrition or BMI <18.5 kg/m2; 15. Remarkable hemorrhagic tendency, Hematological diseases, or myelosuppression; 16. History of any malignancy within 5 years; 17. Pregnant women, lactation, or plan to pregnant within 1 year; 18. Acute or severe system infection; 19. Subject for another clinical trial; 20. Any known drug or alcohol dependence, difficulty understanding the test protocol, inability or unwillingness to follow up with the test protocol; 21. Patients with moderate to severe cognitive impairment and no permanent guardian; 22. Patients considered unsuitable for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Burden of atrial fibrillation;

Secondary

MeasureTime frame
Life quality;Frequency of atrial fibrillation;

Countries

China

Contacts

Public ContactWei Xu

Affiliated Drum Tower Hospital, Nanjing University School of Medicine

13390900868@163.com+86 13390900868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026