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Effectiveness of SGLT2 inhibitors for cardiac remodeling after catheter ablation in atrial fibrillation patients with elevated natriuretic peptides: a prospective, open-label, randomized, blank-control trial

Effect of SGLT2 inhibitors on NT-proBNP after catheter ablation in patients with atrial fibrillation: a prospective, open-label, randomized, blank-control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063482
Enrollment
Unknown
Registered
2022-09-08
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Atrial fibrillation

Interventions

Experimental group:Conventional treatment and dapagliflozin
Ctrol group:Conventional treatment

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-85 years; 2. Symptomatic atrial fibrillation; 3. Catheter ablation of atrial fibrillation for the first time; 4. NT-probNP > 365 pg/mL at the first admission; 5. Left atrial diameter >= 40 mm; 6. Understand, voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Having a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, unstable angina pectoris, etc.) or undergoing cardiac surgery in the past 3 months; 2. Systolic blood pressure less than 100 mmHg (two consecutive measurements with 5 minutes apart) with hypotension symptoms on admission; 3. Severe valvular heart disease (moderate to severe aortic and mitral valve diseases); 4. Lactation, pregnancy or women with pregnancy plans during follow-up; 5. Previous or current use of SGLT2i and SGLT1/SGLT2 combination inhibitors; 6. Known hypersensitivity to SGLT2i; 7. Type 1 diabetes; 8. History of diabetic ketoacidosis; 9. Any other serious disease or condition such as: (1) Malignant tumors; (2) History of chronic infectious diseases; (3) Impaired renal function, defined as estimated glomerular filtration rate (according to the CKD-EPI equation) <30 mL/min/1.73 m2 or require hemodialysis treatment at screening; (4) Moderate or severe liver injury (Child-Pugh grade B or C); (5) Anemia, defined as hemoglobin < 90 g/L; (6) Systemic diseases requiring hormonal treatment; (7) Severe cognitive impairment or dementia; (8) Alcohol or drug abuse; (9) Life expectancy < 12 months; (10) Poor compliance; 10. Participating in other intervention studies.

Design outcomes

Primary

MeasureTime frame
N-terminal pro-B type natriuretic peptide;

Secondary

MeasureTime frame
Left atrial volume index (measured by transthoracic echocardiography);Recurrence of atrial fibrillation/atrial flutter/atrial tachycardia;Atrial fibrillation burden;Quality of life (AFEQT, Atrial Fibrillation Effection Quality of Life);Changes of other transthoracic echocardiographic parameters (left ventricular end-diastolic diameter, left ventricular end-systolic diameter, pulmonary artery systolic pressure, left ventricular ejection fraction);

Countries

China

Contacts

Public ContactZhou Jingmin

Zhongshan Hospital, Fudan University

zhou.jingmin@zs-hospital.sh.cn+86 21 64041990

Outcome results

None listed

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