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NCT05489549 · ClinicalTrials.gov registry record
Subclinical Transthyretin Cardiac Amyloidosis in V122I TTR Carriers
A clinical trial of Amyloidosis Cardiac and Amyloidosis, Hereditary, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- 500
- Enrollment target
- 3
- Study locations
NCT05489549: Recruiting study of Amyloidosis Cardiac and Amyloidosis, Hereditary, sponsored by University of Texas Southwestern Medical Center.
NCT05489549 is a study of Amyloidosis Cardiac and Amyloidosis, Hereditary that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 500 participants. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05489549, a study of Amyloidosis Cardiac and Amyloidosis, Hereditary, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 3
- Study locations
Study 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-sp
Primary Outcome
ECV expansion represents interstitial expansion from amyloid infiltration and greater levels can distinguish amyloidosis from other hypertrophic cardiomyopathies and correlate with cardiac amyloidosis disease severity.
Conditions Studied
Study Locations (3)
New York
- Columbia University Medical Center - New York
Ohio
- Cleveland Clinic - Cleveland
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2027-06-30 |
What NCT05489549 shows while recruiting
NCT05489549 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 5 conditions, with Amyloidosis Cardiac appearing as the primary indexed condition, and to 0 interventions.
NCT05489549 reports a single indexed study location in New York, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT05489549 about?
NCT05489549 is a clinical study titled "Subclinical Transthyretin Cardiac Amyloidosis in V122I TTR Carriers". 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) worldwid...
What is the current status of trial NCT05489549?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2022-11-21. Estimated completion is 2027-06-30.
What conditions does trial NCT05489549 study?
This clinical trial studies the following conditions: Amyloidosis Cardiac, Amyloidosis, Hereditary, Amyloidosis, Familial, Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy, Transthyretin Gene Mutation.
Who is sponsoring clinical trial NCT05489549?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05489549 being conducted?
This trial has 3 study locations across New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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