APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Korábbi kezelés

• Received prior TTR lowering treatment
• Prior or planned heart, liver, or other organ transplant

Más betegség

• New York Heart Association heart failure classification of III and at high risk
• New York Heart Association heart failure classification of IV
• Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
• Has non-amyloid disease that significantly affects ability to walk (e.g., severe chronic obstructive pulmonary disease, severe arthritis, or peripheral vascular disease affecting ambulation)

Laborértékek

• Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2

Egyéb

• Known primary amyloidosis (AL) or leptomeningeal amyloidosis.
• Neuropathy requiring cane or stick to walk, or is wheelchair bound
• Abnormal liver function
• Other cardiomyopathy not related to ATTR amyloidosis

• Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hereditary ATTR amyloidosis with cardiomyopathy or wild-type ATTR amyloidosis with cardiomyopathy
• Medical history of heart failure with at least 1 prior hospitalization for heart failure, or current clinical evidence (signs and symptoms of heart failure)
• Clinically stable with no cardiovascular related hospitalizations within 6 weeks of study start
• Has never taken tafamidis before (tafamidis naïve) or currently on tafamidis for ≥6 months with evidence of disease progression while on tafamidis treatment
• Able to complete ≥150 m on the 6-minute walk test
• Screening N-terminal pro B-type natriuretic peptide (NT-proBNP), a blood marker of heart failure severity, \>300 ng/L and \<8500 ng/L; in participants with permanent or persistent atrial fibrillation, screening NT-proBNP\> 600 ng/L and \<8500 ng/L