Calcific Aortic Valve Stenosis
Conditions
Brief summary
Change in peak aortic jet velocity from baseline to month 36, Change in aortic valve calcium score from baseline to month 36
Detailed description
Change in lipoprotein(a) levels from baseline to month 12, Change in fibrocalcific thickening of the aortic valve from baseline to month 36, Time from randomization to first occurrence of composite clinical endpoint event, defined as reaching either: • Unplanned CAVS related hospital admission • Aortic valve intervention • Death related to calcific aortic valve stenosis, Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to end of study
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak aortic jet velocity from baseline to month 36, Change in aortic valve calcium score from baseline to month 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in lipoprotein(a) levels from baseline to month 12, Change in fibrocalcific thickening of the aortic valve from baseline to month 36, Time from randomization to first occurrence of composite clinical endpoint event, defined as reaching either: • Unplanned CAVS related hospital admission • Aortic valve intervention • Death related to calcific aortic valve stenosis, Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to end of study | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain
Outcome results
None listed