Skip to content

Clinical intervention and follow-up study of atrial fibrillation combined with preserved ejection fraction heart failure patients

Clinical intervention and follow-up study of atrial fibrillation combined with preserved ejection fraction heart failure patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115173
Enrollment
Unknown
Registered
2025-12-23
Start date
2024-04-05
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Atrial Fibrillation Combined with Heart Failure with Preserved Ejection Fraction

Interventions

Trial group:Administer empagliflozin 10mg/day
Control group:Administer 10mg/day of starch tablets

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary signing of informed consent form; 2. Promise to comply with research procedures and cooperate in implementing the entire research process; 3. 18 < age <= 75 years old; 4. Complies with the diagnosis of atrial fibrillation and meets the criteria for performing cardiac catheterization; 5. Meets the diagnostic criteria for HFpEF; 6. If it is a female in the reproductive period, she should use contraception for at least one month before screening and commit to using contraception throughout the entire study period until the end of the study.

Exclusion criteria

Exclusion criteria: 1. Exclude patients with severe valve disease (defined as a history of aortic or mitral valve replacement or repair, moderate or severe aortic or mitral regurgitation, or moderate or severe aortic or mitral stenosis); 2. Exclude patients with elevated myocardial enzymes and ischemic changes on electrocardiogram caused by coronary heart disease, myocardial infarction, etc; 3. Exclude patients with organic heart diseases such as dilated cardiomyopathy and hypertrophic cardiomyopathy; 4. Exclude patients with pericarditis and pericardial effusion; 5. Exclude patients who have undergone previous cardiac catheter ablation and other major cardiovascular surgeries; 6. Exclude patients with implanted pacemakers and defibrillators; 7. Exclude patients currently taking SGLT-2 inhibitors; 8. Exclude patients with gastrointestinal diseases that interfere with drug absorption; 9. Exclude patients with impaired liver function (defined as alanine aminotransferase or aspartate aminotransferase or alkaline phosphatase levels exceeding 3 times the upper limit of normal); 10. Exclude patients with impaired renal function (defined as estimated glomerular filtration rate < 20 ml/min/1.73 m^2).

Design outcomes

Primary

MeasureTime frame
NYHA heart function classification, KCCQ score;Left atrial pressure;Time to first recurrence of atrial fibrillation in patients;

Secondary

MeasureTime frame
Lnterleukin-6;Time to first event of cardiovascular death or rehospitalization due to atrial fibrillation or heart failure symptoms in patients.;Cardiovascular outcome indicators in terms of electrophysiological, imaging, and biological parameters.;

Countries

China

Contacts

Public ContactCui Bo

Renmin Hospital of Wuhan University

cuibo1979@163.com+86 139 0865 4405

Outcome results

None listed

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