Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.
Conditions
Brief summary
Time to first occurrence of any component of the composite of cardiovascular (CV) death, hospitalization for heart failure (HHF), or urgent heart failure (HF) visit.
Detailed description
1. Total number of HF events (first and recurrent; HHF and urgent HF visit)., 2. Change from baseline to Week 52 in a prespecified heart failure patient‑reported outcome total score among participants with baseline value below a prespecified threshold., 3. Time to first occurrence of composite of all cause death, HHF, myocardial infarction (MI), or stroke (4point MACE).
Interventions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of any component of the composite of cardiovascular (CV) death, hospitalization for heart failure (HHF), or urgent heart failure (HF) visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total number of HF events (first and recurrent; HHF and urgent HF visit)., 2. Change from baseline to Week 52 in a prespecified heart failure patient‑reported outcome total score among participants with baseline value below a prespecified threshold., 3. Time to first occurrence of composite of all cause death, HHF, myocardial infarction (MI), or stroke (4point MACE). | — |
Outcome results
None listed