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Heart scans may predict survival in rare amyloid disease

NCT ID NCT04392960

Knowledge-focused Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looked at 30 people newly diagnosed with cardiac AL amyloidosis, a rare disease where abnormal proteins damage the heart. Researchers used advanced MRI, echocardiogram, and PET scans to see if these images could predict survival and show how well chemotherapy works. The goal was to learn which imaging measures are most useful for tracking the disease, not to test a new treatment.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Jul 2020

Finished

Jun 2025

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.

Ages

18 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 more than 18; * histological diagnosis of AL amyloidosis; * measurable cardiac involvement as per current response criteria (i.e. NT-proBNP \>650 ng/L); * measurable hematologic disease (dFLC \>20 mg/L); * adequate renal function (eGFR \>30 mL/min) in order to be safely administered gadolinium; * absence of atrial fibrillation with uncontrolled heart rate; * absence of implantable cardiac devices; * absence of pulmonary amyloidosis histologically documented; * plan to start anti-plasma cell chemotherapy; * plan to assess response at the Pavia center after 6 months; * have given written informed consent to participate. Exclusion Criteria: * non-AL amyloidosis; * NYHA class IV; * PS-ECOG \>3; * severe allergy to paramagnetic tracer; * severe claustrophobia; * pregnant or nursing women;

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Conditions

The condition(s) this trial relates to.

AL amyloidosis amyloidosis Immunoglobulin Light-chain Amyloidosis

As listed by the trial registrant

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

Al amyloidosis

Contacts and locations

Locations

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

More trials for these conditions

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