Chronic HF and comorbid impairment of kidney function who had a recent HF event to evaluate the effect of balcinrenone/dapagliflozin versus dapagliflozin alone on HF events and cardiovascular (CV) death
Conditions
Brief summary
Time to first occurrence of any of the components of the composite of: • CV death • HF hospitalisation • HF event without hospitalisation
Detailed description
1. Total occurrences (first and recurrent) of the components of the composite of: • CV death • HF hospitalisation • HF event without hospitalisation, 2. Total occurrences (first and recurrent) of HF hospitalisations, 3. Time to CV death, 4. The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation, 5.Time to death from any cause
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 of the components of the composite of: • CV death • HF hospitalisation • HF event without hospitalisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total occurrences (first and recurrent) of the components of the composite of: • CV death • HF hospitalisation • HF event without hospitalisation, 2. Total occurrences (first and recurrent) of HF hospitalisations, 3. Time to CV death, 4. The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation, 5.Time to death from any cause | — |
Countries
Austria, Bulgaria, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain, Sweden
Outcome results
None listed