Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Conditions
Brief summary
Change in serum TTR level from baseline to month 6 or premature discontinuation of treatment
Detailed description
Serum TTR level at baseline, week 1, 2, 3, 4 and at month 3., Occurrence of TEAEs and type of TEAEs and serious TEAEs., Change from baseline to month 6 of NT-proBNP, hs-TnT, hs-CRP, RBP4., Signs of remodeling from baseline to month 6 in ECHO., Change from baseline to month 6 in 6MWD, Change from baseline to month 6 in kidney and thyroid biomarkers: eGFR, Creatinine, Cystatin C, UACR, and TSH., Change from baseline to month 6 in KCCQ-OS score and in EQ-5D-5L index score.
Interventions
Sponsors
Bayer Consumer Care AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum TTR level from baseline to month 6 or premature discontinuation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum TTR level at baseline, week 1, 2, 3, 4 and at month 3., Occurrence of TEAEs and type of TEAEs and serious TEAEs., Change from baseline to month 6 of NT-proBNP, hs-TnT, hs-CRP, RBP4., Signs of remodeling from baseline to month 6 in ECHO., Change from baseline to month 6 in 6MWD, Change from baseline to month 6 in kidney and thyroid biomarkers: eGFR, Creatinine, Cystatin C, UACR, and TSH., Change from baseline to month 6 in KCCQ-OS score and in EQ-5D-5L index score. | — |
Outcome results
None listed