Variant or wild-type transthyretin (TTR) amyloid cardiomyopathy
Conditions
Brief summary
Number of occurrences of the composite endpoint consisting of: • CV death • Recurrent CV events (CV hospitalisation and urgent HF visits )
Detailed description
Secondary Confirmatory: Change in KCCQ-CSS, Change in 6MWD, Number of occurrences of CV events (CV hospitalisation and urgent HF visits), Time to occurrence of CV death, Time to occurrence of all-cause death, Time to first occurrence of composite CKD endpoint: • CV death • Onset of persistent decline eGFR ≥ 30% • Onset of persistent eGFR < 15 mL/min/1.73m2 • Initiation of chronic kidney replacement therapy (dialysis or kidney transplant), Change in KCCQ-OSS
Interventions
DRUGliquid dosage form in 20 mL vials with 11 extractable volume
DRUGcoramitug C 10035
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary Confirmatory: Change in KCCQ-CSS, Change in 6MWD, Number of occurrences of CV events (CV hospitalisation and urgent HF visits), Time to occurrence of CV death, Time to occurrence of all-cause death, Time to first occurrence of composite CKD endpoint: • CV death • Onset of persistent decline eGFR ≥ 30% • Onset of persistent eGFR < 15 mL/min/1.73m2 • Initiation of chronic kidney replacement therapy (dialysis or kidney transplant), Change in KCCQ-OSS | — |
Primary
| Measure | Time frame |
|---|---|
| Number of occurrences of the composite endpoint consisting of: • CV death • Recurrent CV events (CV hospitalisation and urgent HF visits ) | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed