Heart Failure With Preserved Ejection Fraction
Conditions
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Provision of signed informed consent prior to any study specific procedures. - Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure 6 or more weeks before enrolment with at least intermittent need for diuretic treatment. - Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required. - Elevated NT-pro BNP levels. - Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation. Further details regarding inclusion criteria 4-6 may apply.
Exclusion criteria
Exclusion criteria: - Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor. - Type 1 diabetes mellitus (T1D). - eGFR 50 kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed