RecruitingNCT05489549

Subclinical Transthyretin Cardiac Amyloidosis in V122I TTR Carriers

Identifying Subclinical Transthyretin Cardiac Amyloidosis in Asymptomatic Carriers of the V122I TTR Allele


Sponsor

University of Texas Southwestern Medical Center

Enrollment

500 participants

Start Date

Nov 21, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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 utility for identifying subclinical hATTR-CA. In Aim 1, CMRI will be used to compare metrics associated with cardiac amyloid infiltration between a cohort of V122I TTR carriers without HF formed by cascade genetic testing and age-, sex-, and race-matched non-carrier controls. For Sub-Aim 1, a sub-sample of carriers and non-carrier controls enrolled in Aim 1 will undergo novel exercise CMRI to measure and compare cardiac systolic and diastolic reserve. Aim 2 involves measuring and comparing amyloid-specific biomarkers in V122I TTR carriers without HF with samples matched non-carriers (both from Aim 1) and individuals with symptomatic V122I hATTR-CA from our clinical sites. These biomarkers detect and quantify different processes of TTR amyloidogenesis and include circulating TTR, retinol binding protein 4, TTR kinetic stability, and misfolded TTR oligomers. Sub-aim 2 will establish the role of these biomarkers to detect imaging evidence of subclinical hATTR-CA disease.


Eligibility

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

People of African ancestry have a higher rate of carrying a genetic variant (V122I) in the TTR gene that can cause heart disease from protein deposits (cardiac amyloidosis). This study aims to understand how and when this heart disease develops — from the early (silent) stages through to full symptoms — using advanced heart imaging like cardiac MRI. You may be eligible if: • You are a man or woman aged 30 to 80 • You carry the V122I TTR genetic variant (or are a matched non-carrier for comparison) • For the group with symptoms: you have been diagnosed with heart failure or have signs of elevated heart failure biomarkers (BNP, NT-proBNP) You may NOT be eligible if: • You have a prior diagnosis of heart failure (for the silent disease group) • You have another known cause of heart muscle disease (cardiomyopathy) • You have had a prior heart attack (type 1 myocardial infarction) • You have had a heart or liver transplant • You weigh more than 250 lbs or have kidney function below eGFR 30 • You cannot safely undergo cardiac MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Columbia University Medical Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT05489549


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