Health Trials

About this trial

The purpose of this study is to determine if TTR gene carriers have early signs of a type of heart disease called amyloidosis using a new radiotracer dye (iodine-124 evuzamitide, I-124E).

Participants will undergo a screening that includes a medical history review and completion of quality-of-life surveys. Once screening is complete, participants will undergo an imaging test called a positron emission tomography (PET) scan combined with computed tomography (PET/CT) to make images of the body. The new radiotracer dye (I-124E, a radioactive contrast) will be used during the PET/CT to make amyloidosis visible in the heart and body.

Eligibility criteria

Qualifiers

men and women ages 30-80 who are pathogenic allele TTR carriers without history of HF (this will be assessed by study personnel and defined as : 1) No history of hospitalization within the previous 12 months for management of HF; 2) Without an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or 3) a clinical diagnosis of HF from a treating clinician)

have already completed the protocol for NCT05489549 at UT Southwestern only

a self-reported history or clinical history of HF

other known causes of cardiomyopathy

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Iodine-124 Evuzamitide (I-124E)

Treatment groups

80 Participants
are divided into 3 treatment groups

Locations

1
UT Southwestern Medical Center75248, DallasTexas, United States

Sponsors and collaborators

University of Texas Southwestern Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Bayer

Collaborator

Source ClinicalTrials.gov