heart failure with preserved ejection fraction
Conditions
Interventions
test group:Empagliflozin
control group:no
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age=18 years, =80 years 2. Symptoms of heart failure have been present for =1 month 3. New York Heart Association Class II-IV 4. Left ventricular ejection fraction > 40% detected by echocardiography within 1 month (no left ventricular ejection fraction 125 pg/mL 6. Echocardiography shows left atrial enlargement and/or left ventricular hypertrophy and/or decreased diastolic function
Exclusion criteria
Exclusion criteria: 1.Patients with acute decompensated heart failure using or requiring intravenous vasodilator or inotropic therapy 2. Diagnosis of invasive heart disease (e.g., myocardial amyloidosis), storage disease (e.g., hemochromatosis, Fabry disease), reversible cardiomyopathy (e.g., stress cardiomyopathy), hypertrophic obstructive cardiomyopathy, constrictive pericarditis, muscular dystrophy, severe valvular heart disease (moderate or severe aortic stenosis, severe aortic stenosis, moderate or severe mitral stenosis, severe mitral valve disease, valvular heart disease with surgery during the intended trial) 3. Diagnosis of acute myocardial infarction, stroke, or transient ischemic attack within the past 3 months, or coronary artery bypass graft, aortic valve replacement, or other major cardiovascular surgery has been performed 4. With implantable cardioverter defibrillator or cardiac resynchronization therapy 5. Sodium glucose cotransporter 2 inhibitors have been used continuously for =3 months 6. Systolic blood pressure >= 180 mmHg and/or symptomatic hypotension and/or systolic blood pressure 110 bpm on electrocardiogram at screening 8. Known hypersensitivity to empagliflozin 9. History of ketoacidosis 10. Pregnant, or currently breastfeeding or planning a pregnancy 11. Any serious disease affecting the clinical course of the subject, such as acute exacerbation of chronic obstructive pulmonary disease, acute or chronic liver disease, severe renal impairment (eGFR < 30 ml/min/1.73 m2 as estimated by CKD-EPI formula or subjects on regular dialysis), severe anemia (hemoglobin < 90 g/L), gastrointestinal surgery or gastrointestinal disease that may affect the absorption of the trial drug, acute or chronic pancreatitis, current urinary or reproductive system infection, any documented active or suspected malignancy or history of malignancy within 1 year before screening 12. Severe hypoglycemia requiring intervention in the past year 13. The presence of any disease that, in the opinion of the investigator, results in a life expectancy of < 1 year, other than heart failure 14. Receiving any other clinical trial of drugs other than this study drug 15. Inability to comply with the schedule of study assessments for follow-up or unsuitability for trial based on the investigator's clinical judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in extracellular volume by cardiac magnetic resonance imaging after 6 months of treatment;Change in left ventricular mass by cardiac magnetic resonance imaging after 6 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of cardiac structure and function by echocardiography after 6 months of treatment;Change of N-terminal pro-B-type natriuretic peptide and biomarkers after 6 months of treatment; | — |
Countries
China
Contacts
Public ContactWang Hua
Beijing Hospital
Outcome results
None listed