Heart failure preserved ejection fraction
Conditions
Interventions
Patients will use either dapagliflozin 10 mg or placebo once daily.
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of signed informed consent prior to any study specific procedures. 2. Male or female patients age *40 years. 3. Documented diagnosis of symptomatic heart failure HFpEF 4. LVEF >40%, measured within the last 12 months prior to enrolment and evidence of structural heart disease. 5. NT-pro BNP *300 pg/ml at Visit 1 for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at Visit 1, NT-pro BNP must be *600 pg/mL. 6. Patients may be ambulatory, or hospitalized; patients must be off intravenous heart failure therapy (including diuretics)
Exclusion criteria
Exclusion criteria: 1. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor 2. Type 1 diabetes mellitus (T1D) 3. eGFR 50 kg/m2 11. Previous cardiac transplantation, or complex congenital heart disease. Planned cardiac resynchronisation therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to (first occurrence of): 1. CV death. 2. Hospitalisation for HF. 3. Urgent HF visit (e.g., emergency department or outpatient visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total number of (first and recurrent) hospitalisations for HF and CV death. 2. Change from baseline in the total symptom score (TSS) of the KCCQ at 8 months. 3. Time to the occurrence of CV death 4. Time to the occurrence of death from any cause. | — |
Countries
Netherlands
Outcome results
None listed