18 Years to 90 Years
Accepting Healthy Volunteers?
- Have an established diagnosis of ATTR-CM with either wild-type TTR or variant TTR
- Have a history of heart failure evidenced by at least one prior hospitalization for
heart failure or clinical evidence of heart failure without prior heart failure
hospitalization manifested by signs or symptoms of volume overload or elevated
intracardiac pressures or heart failure symptoms that required or require ongoing
treatment with a diuretic.
- New York Heart Association (NYHA) Class I-III symptoms due to ATTR cardiomyopathy.
- On stable doses of cardiovascular medical therapy
- Completed ≥150 m on the 6MWT on 2 consecutive tests
- Biomarkers of myocardial wall stress, NT-proBNP level ≥300 pg/mL
- Have left ventricular wall (interventricular septum or left ventricular posterior
wall) thickness ≥13 mm
- Had acute myocardial infarction, acute coronary syndrome or coronary
revascularization, or experienced stroke within 90 days
- Has hemodynamic instability
- Likely to undergo heart transplantation within a year of screening
- Confirmed diagnosis of primary (light chain) amyloidosis
- Biomarkers of myocardial wall stress, NT-proBNP level ≥7000 pg/mL pg/mL
- Measure of kidney function, eGFR by MDRD formula < 15 mL/min/1.73 m2
- Current treatment with other investigational agents for the treatment of ATTR-CM
- Current treatment with calcium channel blockers or digitalis