Empagliflozin on the Function of Left Atrium in Heart Failure With Mildly Reduced or Preserved Ejection Fraction

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The number of heart failure with mildly reduced or preserved ejection fraction gradually increases. SGLT2-i has been shown to reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or more . However,its effect on the function on left atrium in heart failure with mildly reduced or preserved ejection fraction is still unknown.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhijun Sun
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• 18≤Age≤80 years

• Meet the definition of heart failure and an ejection fraction of 40% or more (according to 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure)

• Elevated NT-proBNP levels (> 300 pg/mL in patients without atrial fibrillation;> 900pg/mL in patients with atrial fibrillation)

• Signed and dated written informed consent form

Exclusion Criteria:

• Myocardial infarction,coronary artery bypass graft surgery, or other major cardiovascular surgery within 30 days after enrollment

• SGLT-2i using before enrollment

• Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease),cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), or known pericardial constriction

• Moderate to severe valvular stenosis or regurgitation

• Implantation of a cardioverter defibrillator or receiving cardiac resynchronization therapy within 90 days prior to enrollment

• Chronic pulmonary disease requiring home oxygen, oral corticosteroid therapy or hospitalization for exacerbation within 12 months

• Other significant co-morbid conditions(impaired renal function( an estimated glomerular filtration rate of <20 mL/min/1.73 m2), hepatic failure, malignant tumors, severe hematologic diseases, etc.)

• Major surgery performed within 90 days prior to enrollment or major scheduled elective surgery within 90 days after enrollment(major according to the investigator's assessment,such as gastrointestinal surgery that might interfere with trial medication absorption or malignant tumors surgery)

• History of ketoacidosis

• Pregnancy

• Completion within 90 days of a trial of another drug study. Receipt of any investigative treatment other than the study medications for this trial