Condition: Amyloidosis, Hereditary · Amyloidosis Cardiac · Amyloidosis, Familial · Sponsor: University of Texas Southwestern Medical Center
Approximately 1.5 million of the 44 million Blacks in the United States are carriers of the valine-to-isoleucine substitution at position 122 (V122I) in the transthyretin (TTR) protein. Virtually exclusive to Blacks, this is the most common cause of hereditary cardiac amyloidosis (hATTR-CA) worldwide. hATTR-CA leads to worsening heart failure (HF) and premature death. Fortunately, new therapies that stabilize TTR improve morbidity and mortality in hATTR-CA, especially when prescribed early in the disease. However, hATTR-CA is often diagnosed at an advanced stage and conventional diagnostic tools lack diagnostic specificity to detect early disease. The overall objectives of this study are to determine the presence of subclinical hATTR-CA and to identify biomarkers that indicate amyloid progression in V122I TTR carriers. The central hypothesis of this proposal is that hATTR-CA has a long latency period that will be detected through subclinical amyloidosis imaging and biomarker phenotyping. The central hypothesis will be tested by pursuing 2 specific aims: Aim 1) determine the association of V122I TTR carrier status with CMRI evidence of amyloid infiltration; Sub-aim 1) determine the association of V122I TTR carrier status with cardiac reserve; Aim 2) determine the association between amyloid-specific biomarkers and V122I TTR carrier status; and Sub-aim 2) determine the association of amyloid-specific biomarkers with imaging-based parameters and evaluate their diagnostic utili…
This description comes directly from the study's public registry record.
Amy Browning · 214-645-8040 · Amy.Browning@utsouthwestern.edu
Lori R Roth, MS, PAC · 214-645-1043 · Lori.Roth@utsouthwestern.edu
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| Columbia University Medical Center | New York, New York, United States | Recruiting |
| Cleveland Clinic | Cleveland, Ohio, United States | Recruiting |
| University of Texas Southwestern Medical Center | Dallas, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05489549