Heart condition
Conditions
Brief summary
The primary endpoint is clinical benefit, defined as a hierarchical composite endpoint of: 1. Time to all-cause mortality 2. Number of total HF events 3. Time to first HF event 4. KCCQ-TSS change from baseline to 6 months of 5 points or greater assessed by the win-ratio method
Detailed description
Secondary endpoints include treatment group difference in: • KCCQ-TSS, mean change from baseline to 6 months • Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF) • Total (first and recurrent) HF events from baseline to 90 days
Interventions
Sponsors
Colorado Prevention Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is clinical benefit, defined as a hierarchical composite endpoint of: 1. Time to all-cause mortality 2. Number of total HF events 3. Time to first HF event 4. KCCQ-TSS change from baseline to 6 months of 5 points or greater assessed by the win-ratio method | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include treatment group difference in: • KCCQ-TSS, mean change from baseline to 6 months • Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF) • Total (first and recurrent) HF events from baseline to 90 days | — |
Countries
Spain
Outcome results
None listed