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New PET scan could spot hidden heart disease

NCT ID NCT07538518

Diagnosis Sponsor: Lorena Saelices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

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.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether a special PET-CT scan using a drug called evuzamitide can detect signs of cardiac amyloidosis in people whose standard heart scans were unclear but who have high levels of a blood marker called TAD1. About 25 adults with heart failure or a genetic risk for this condition will receive one scan and be followed for about a month. The goal is to improve diagnosis for this serious heart disease.

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 25 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

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

Participants will be drawn from clinical practice registries and epidemiological ATTR-CA screening projects at UT Southwestern, Columbia University Irving Medical Center, and Boston Medical Center

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: 1. Diagnosed as having heart failure or TTR variant allele carriers without symptoms of heart failure. 2. Non-diagnostic nuclear scintigraphy for ATTR-CA (Perugini Grade 0 or 1). 3. Elevated levels of Transthyretin Amyloid Detector-1 (TAD1). 4. No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine. 5. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements. 6. Able to understand and sign the informed consent document after the nature of the study has been fully explained. Exclusion Criteria: 1. Primary amyloidosis (AL) or secondary amyloidosis (AA). 2. Ventricular assist device. 3. Disabling dementia or other mental or behavioral disease. 4. Enrollment in a clinical trial not approved for co-enrollment. 5. Continuous intravenous inotropic therapy. 6. Inability or unwillingness to comply with the study requirements. 7. Chronic kidney disease requiring hemodialysis or peritoneal dialysis. 8. Patients taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation. 9. Other reason that would make the subject inappropriate for entry into this study. 10. Pregnancy or current lactational feeding of infants.

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial amyloidosis familial amyloid neuropathy wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyloidogenic transthyretin (ATTR) amyloidosis Cardiac amyloidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Bill and Rita Clements Advanced Medical Imaging Center

    Dallas, Texas, 75235-8823, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • One Boston Medical Center Place

    Boston, Massachusetts, 02118, United States

More trials for these conditions

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