Key exclusion criteria include: recent treatment with or intolerance of a SGLT2 inhibitor, type 1 diabetes mellitus, symptoms of hypotension or systolic blood pressure < 95 mmHg, recent worsening heart failure or other cardiovascular events or procedures (or planned procedures), estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (or rapidly declining renal function) and other conditions likely to prevent patient participation in the trial or greatly limit life expectancy. A full list of exclusion criteria is provided in Table
Evaluating SGLT2 Inhibitors in Heart Failure
Key exclusion criteria include: recent treatment with or intolerance of a SGLT2 inhibitor, type 1 diabetes mellitus, symptoms of hypotension or systolic blood pressure < 95 mmHg, recent worsening heart failure or other cardiovascular events or procedures (or planned procedures), estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (or rapidly declining renal function) and other conditions likely to prevent patient participation in the trial or greatly limit life expectancy. A full list of exclusion criteria is provided in Table
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Corresponding Organization : University of Glasgow
Other organizations : University of Wisconsin–Madison, Yale University, Copenhagen University Hospital, Rigshospitalet, Saint Luke's Hospital, University of Missouri–Kansas City, The George Institute for Global Health, AstraZeneca (Sweden), Universidad Nacional de Córdoba, Wroclaw Medical University, Thrombolysis in Myocardial Infarction Study Group, Brigham and Women's Hospital, Harvard University
Protocol cited in 5 other protocols
Variable analysis
- Treatment with a SGLT2 inhibitor
- Heart failure outcomes
- Men and women aged 18 years or older with a diagnosis of heart failure for at least 2 months
- New York Heart Association functional class II or above
- Left ventricular ejection fraction documented to be ≤ 40% within the last 12 months
- Optimally treated with pharmacological and device therapy for heart failure
- N-terminal pro B-type natriuretic peptide concentration ≥ 600 pg/mL or, if hospitalised for heart failure within the previous 12 months, ≥ 400 pg/mL
- For patients with atrial fibrillation or atrial flutter, N-terminal pro B-type natriuretic peptide concentration ≥ 900 pg/mL, irrespective of history of heart failure hospitalization
- Exclusion criteria: recent treatment with or intolerance of a SGLT2 inhibitor, type 1 diabetes mellitus, symptoms of hypotension or systolic blood pressure < 95 mmHg, recent worsening heart failure or other cardiovascular events or procedures (or planned procedures), estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 (or rapidly declining renal function) and other conditions likely to prevent patient participation in the trial or greatly limit life expectancy
- Not explicitly mentioned
- Not explicitly mentioned
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