Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

Inclusion Criteria:

• Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF orclinical evidence of HF (without hospitalization) manifested by signs or symptoms ofvolume overload or elevated intracardiac pressures (e.g., elevated jugular venouspressure, shortness of breath or signs of pulmonary congestion on x-ray orauscultation, peripheral edema) that required/requires treatment with a diuretic forimprovement,

• Evidence of cardiac involvement by echocardiography with an end-diastolicinterventricular septal wall thickness > 12 mm,

• Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotypeand/or TTR precursor protein identification by immunohistochemistry, scintigraphy ormass spectrometry

Exclusion Criteria:

• A New York Heart Association (NYHA) classification of IV.

• Presence of primary (light chain) amyloidosis.

• Prior liver or heart transplantation or implanted cardiac mechanical assist device.