New scan spots hidden heart disease in gene carriers before symptoms start
NCT ID NCT07591038
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to see if a new radioactive dye can detect early signs of a heart condition called amyloidosis in people who carry a TTR gene mutation but have no heart failure symptoms. About 80 adults aged 30-80 will receive an injection of the dye and then have a PET/CT scan to look for amyloid buildup in the heart. The goal is to find disease earlier so treatment can begin sooner.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
We will enroll 50 carriers of pathogenic TTR alleles without HF, 20 patients with ATTR-CA, and 10-race matched non-carrier controls to have PET/CT I-124E imaging.
- Ages
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30 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
A. Pathogenic TTR Allele Carriers without HF Inclusion: * 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 Exclusion: * a self-reported history or clinical history of HF * other known causes of cardiomyopathy * history of light-chain cardiac amyloidosis * prior type 1 myocardial infarction * cardiac transplantation * liver transplantation * body weight or habitus that exceeds the site-specific PET/CT parameters * estimated glomerular filtration rate ≤30 mL/min/1.73 m2 * inability to safely undergo PET/CT * participating in a clinical trial for ATTR treatments or taking a fibril deleting agent * pregnancy or breastfeeding * patients taking heparin or heparin derivatives for anticoagulation * allergy to potassium iodide * known uncorrected thyroid disorder B. Subjects with symptomatic hATTR-CA (may be supplemented with other ATTR-CA genotypes including wild-type in the occasion of slow enrollment): Inclusion: * men and women ages 30-80 who have symptomatic V122I hATTR-CA as determined by a history of HF (this will be assessed by study personnel and defined as : 1) history of hospitalization within the previous 12 months for management of HF; 2) 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) * hATTR-CA previously diagnosed histologically by amyloid staining and tissue typing with immunohistochemistry or mass spectrometry or by bone scintigraphy in without abnormal M-protein * TTR gene sequencing confirming the TTR variant * have already completed the protocol for NCT05489549 at UT Southwestern only Exclusion: * other known causes of cardiomyopathy * history of light-chain cardiac amyloidosis * cardiac transplantation * liver transplantation * history of type I myocardial infarction * body weight or habitus that exceeds the site-specific PET/CT parameters * estimated glomerular filtration rate ≤30 mL/min/1.73 m2 * inability to safely undergo PET/CT * participating in a clinical trial for ATTR treatments or taking a fibril deleting agent * patients taking heparin or heparin derivatives for anticoagulation * pregnancy or breastfeeding * allergy to potassium iodide * known uncorrected thyroid disorder C. Non-carrier race-matched controls: Inclusion: * men and women ages 30-80 who are non-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) No clinical diagnosis of HF from a treating clinician * have previously enrolled in the Dallas Heart Study Exclusion: * a self-reported history or clinical history of HF * other known causes of cardiomyopathy * history of light-chain cardiac amyloidosis * prior type 1 myocardial infarction * cardiac transplantation * liver transplantation * body weight or habitus that exceeds the site-specific PET/CT parameters * estimated glomerular filtration rate ≤30 mL/min/1.73 m2 * inability to safely undergo PET/CT * participating in a clinical trial for ATTR treatments or taking a fibril deleting agent * patients taking heparin or heparin derivatives for anticoagulation * pregnancy or breastfeeding * allergy to potassium iodide * known uncorrected thyroid disorder
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT Southwestern Medical Center
Dallas, Texas, 75248, United States
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