Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology (TTRACK)

Pfizer

Status: Completed

Conditions: Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Treatments: Diagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy

Study type: Observational

Funder types: Industry

Identifiers

NCT03842163

B3461058

TTRACK (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol

Enrollment: 812 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient signed inform consent.
• Males and Females.
• Age ≥50 years.
• Left ventricular hypertrophy (LVH) defined as end-diastolic LV maximum wall thickness (MWT) ≥15mm in Echocardiogram.
• Plan to undergo or recently underwent radionuclide bone scintigraphy and/or SPECT with any of the following radio labelled tracers: 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP.

Exclusion criteria

• Etiological diagnosis explaining the LVH (p.e. Sarcomeric HCM, Myeloma, Fabry disease, Sarcoidosis, Any type of amyloidosis (AA, AL, TTR)
• Severe aortic stenosis defined as aortic valve area (AVA) < 1.0 cm2

Trial design

812 participants in 1 patient group

Patients with LVH of unknown etiology

Treatment:

Diagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy