B3461087 - Tafamidis

  • participants needed
  • sponsor
Updated on 9 June 2022


This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved ejection fraction (HFpEF)].


Condition Transthyretin Amyloid Cardiomyopathy, Heart Failure With Preserved Ejection Fraction
Clinical Study IdentifierTX286030
Last Modified on9 June 2022


Yes No Not Sure

Inclusion Criteria

Medical history of heart failure (HF) with
At least 1 episode with clinical evidence of HF (without hospitalization) by signs or symptoms of volume overload or elevated intracardiac pressures that required/requires treatment with a diuretic for improvement; OR
1 prior hospitalization for HF
Left ventricular ejection fraction (LVEF) >40%
End-diastolic interventricular septal wall thickness (IVST) ≥12 mm
Willing and able to undergo scintigraphy

Exclusion Criteria

Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%)
Prior clinical history of myocardial infarction, CABG or multi-vessel obstructive coronary disease (>50% stenosis of ≥2 epicardial coronary arteries)
Presence or history of any severe valvular heart disease (obstructive or regurgitant)
A confirmed diagnosis of a non-amyloid infiltrative cardiomyopathy (ie, cardiac sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy with known genetic etiology, or known pericardial constriction
Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary [light chain] amyloidosis) or prior diagnosis of ATTR-CM
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