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New scan spots hidden heart disease in gene carriers before symptoms start

NCT ID NCT07591038

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

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

30 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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How to take part

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Contacts and locations

Locations

  • UT Southwestern Medical Center

    Dallas, Texas, 75248, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.