An Open-Label Study to Investigate the Long-Term Effects of Acoramidis on Cardiac Function, Structure and Cardiac Amyloid Burden in Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Conditions

Transthyretin Amyloidosis

Brief summary

Response based on improved LVEF or LVSVi at Month 36, Incidence of treatment-emergent AEs, SAEs

Detailed description

1. Response based on improved or stabilized LVEF AND improved or stabilized LVSVi at Month 36., 2. Response based on stabilized LVEF AND stabilized LVSVi at Month 36., 3. LVEF, at Month 36: - Mean change from baseline in LVEF - Response based on improved LVEF -Response based on improved or stabilized LVEF - Response based on stabilized LVEF, 4. LVSVi, at Month 36: - Mean change from baseline in LVSVi - Response based on improved LVSVi - Response based on improved or stabilized LVSVi - Response based on stabilized LVSVi, 5. LVGLS, at Month 36: - Mean change from baseline in LVGLS - Response based on improved LVGLS - Response based on improved or stabilized LVGLS - Response based on stabilized LVGLS, 6. LVMi, at Month 36: - Mean change from baseline in LVMi - Response based on improved LVMi - Response based on improved or stabilized LVMi - Response based on stabilized LVMi, 7. ECV, at Month 36: - Mean change from baseline in ECV - Response based on improved ECV - Response based on improved or stabilized ECV - Response based on stabilized ECV

Related papers

No related papers found yet.

Interventions

DRUGBEYONTTRA 356 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Response based on improved LVEF or LVSVi at Month 36, Incidence of treatment-emergent AEs, SAEs	—

Secondary

Measure	Time frame
1. Response based on improved or stabilized LVEF AND improved or stabilized LVSVi at Month 36., 2. Response based on stabilized LVEF AND stabilized LVSVi at Month 36., 3. LVEF, at Month 36: - Mean change from baseline in LVEF - Response based on improved LVEF -Response based on improved or stabilized LVEF - Response based on stabilized LVEF, 4. LVSVi, at Month 36: - Mean change from baseline in LVSVi - Response based on improved LVSVi - Response based on improved or stabilized LVSVi - Response based on stabilized LVSVi, 5. LVGLS, at Month 36: - Mean change from baseline in LVGLS - Response based on improved LVGLS - Response based on improved or stabilized LVGLS - Response based on stabilized LVGLS, 6. LVMi, at Month 36: - Mean change from baseline in LVMi - Response based on improved LVMi - Response based on improved or stabilized LVMi - Response based on stabilized LVMi, 7. ECV, at Month 36: - Mean change from baseline in ECV - Response based on improved ECV - Response based on	—

Measure

Time frame

1. Response based on improved or stabilized LVEF AND improved or stabilized LVSVi at Month 36., 2. Response based on stabilized LVEF AND stabilized LVSVi at Month 36., 3. LVEF, at Month 36: - Mean change from baseline in LVEF - Response based on improved LVEF -Response based on improved or stabilized LVEF - Response based on stabilized LVEF, 4. LVSVi, at Month 36: - Mean change from baseline in LVSVi - Response based on improved LVSVi - Response based on improved or stabilized LVSVi - Response based on stabilized LVSVi, 5. LVGLS, at Month 36: - Mean change from baseline in LVGLS - Response based on improved LVGLS - Response based on improved or stabilized LVGLS - Response based on stabilized LVGLS, 6. LVMi, at Month 36: - Mean change from baseline in LVMi - Response based on improved LVMi - Response based on improved or stabilized LVMi - Response based on stabilized LVMi, 7. ECV, at Month 36: - Mean change from baseline in ECV - Response based on improved ECV - Response based on

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Outcome results

None listed