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New imaging technique may predict heart events in amyloidosis patients

NCT ID NCT07154381

Knowledge-focused Sponsor: University Hospital, Essen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study is testing whether a special type of PET/MRI scan using a radioactive tracer called florbetaben can help predict major heart problems in people with cardiac amyloidosis. The researchers will follow 25 patients to see if certain scan results are linked to serious events like heart failure hospitalization or death. The goal is to find better ways to identify who is at highest risk, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Florbetaben (a radioactive tracer used in PET imaging)
What this could lead to
If successful, this study could identify imaging markers that help predict serious heart events in cardiac amyloidosis patients, potentially guiding earlier or more personalized care.
What could go wrong
This is a small, early observational study with only 25 participants. It is not testing a treatment, so it will not directly improve outcomes. The results may not apply to all patients.

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.

Started

Dec 2019

Expected to finish

Dec 2025

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

Patients with proven amyloidosis with no competing amyloidosis treatments, willing and capable of undergoing Florbetaben PET/MRI.

Ages

40 years and older

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: * Age \> 40 years * proven Amyloidosis (ATTR or AL) * Women: negative pregnancy test less than weeks prior imaging. Exclusion Criteria: * Patients receiving amyloidosis-specific treatment prior study inclusion. * Patients participating in other clinical trails for treatment of Amyloidosis. * Pregnancy * Contraindiactions for MRI (eGFR\<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for 3T MRI). * inability of consent * Refusal of consent

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial amyloidosis

As listed by the trial registrant

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

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

    1 site. 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

  • Department of Nuclear medicine, University Hospital Essen

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

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