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Enrolling By Invitation NCT05600387

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

Conditions: Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction

Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 100
Sponsor: Zhijun Sun

Location: China

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.

Eligibility Criteria

Inclusion Criteria:Age ≥ 18 years old, BMI18.5-27.9kg/m²Meet the definition of chronic 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 formExclusion Criteria:Myocardial infarction,coronary artery bypass graft surgery, or other major cardiovascular surgery within 30 days after enrollmentPercutaneous coronary intervention ,coronary artery bypass graft surgery,cardiac resynchronization therapy, implantable cardioverter defibrillatoror or other cardiac surgeries within 90 days prior to enrollmentSGLT-2i using within 90 days prior to enrollmentCardiomyopathy 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 constrictionAcute decompensated heart failure.Moderate to severe valvular stenosis or regurgitationSymptomatic hypotension with systolic pressure ≤ 90mmHg or uncontrolled hypertension using drugs with systolic blood pressure of ≥180 mmHg at randomizationSever infectious diseases(e.g. Severe myocarditis, severe pneumonia, and severe urinary tract infection)Chronic pulmonary disease requiring home oxygen, oral corticosteroid therapy or hospitalization for exacerbation within 12 monthsOther 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)Type 1 diabetes or history of ketoacidosisPregnancyCompletion within 90 days of a trial of another drug study. Receipt of any investigative treatment other than the study medications for this trial

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05600387). StuddyBuddy aggregates publicly available trial information.