Clinical Trials

Inclusion Criteria:

• Adult, age 20 and greater.

• Subject is clinically stable without cardiovascular-related hospitalizations within 6 weeks prior to enrollment as assessed by the investigators.

• Subject is able to provide written informed consent and is willing and able to complete study procedures.

• Subject must meet criteria for either ATTR cardiac amyloidosis or AL cardiac amyloidosis from review of medical records as specified below:

  • ATTR cardiac amyloidosis based on meeting all the following criteria:  

    • Diagnosis of amyloidosis within ten years prior to study screening

    • Transthyretin amyloid deposits in cardiac tissue

    • Technetium (99mTc) bone scintigraphy with grade 2 or 3 cardiac uptake

    • Transthyretin amyloid deposits in non-cardiac tissue with echocardiographic evidence of cardiac involvement or an end-diastolic mean wall thickness > 12 mm

    • Transthyretin amyloid deposits in non-cardiac tissue with cardiac MRI diagnostic of amyloidosis.

  • AL cardiac amyloidosis based on meeting all the following criteria: 

    • Diagnosis of amyloidosis within ten years prior to study screening

    • Histopathologic diagnosis of amyloidosis with AL protein identification

    • Cardiac involvement as defined by:

    • Amyloid deposits in cardiac deposits

    • Echocardiography with an end-diastolic mean wall thickness > 12 mm in the absence of other causes

    • Elevated NT-proBNP (>332 ng/L) in the absence of renal failure or atrial fibrillation.

    • Cardiac MRI diagnostic of amyloidosis

Exclusion Criteria:

• Unable to consent or unable to complete all study procedures.

• Unable to ambulate for 6 minutes (confirmed at study coordinator visit)

• Unable to maintain in supine position for 30 minutes.

• Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator visit)

• Contraindications for safe MRI scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)

• Presence of implantable cardiac pacemaker or defibrillator.

• History of complex congenital heart disease, intracardiac shunt (except for patent foramen ovale), prosthetic valves, prosthesis in the main pulmonary artery or ascending thoracic aorta.

• Significant artifact from prior MRI studies.

• Pregnant or breast-feeding women.

• Weight equal to or greater than 155 kg .

• In the judgment of the investigator, has clinically relevant ongoing medical condition or laboratory abnormalities or other condition that might jeopardize the participants safety, increase the participants risk from participation, interfere with the study, or confirmed study results.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/23/2025. Questions regarding updates should be directed to the study team contact.