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Liver clues: a new way to stage heart amyloidosis?

NCT ID NCT07766135

Knowledge-focused Sponsor: University of Messina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study looks at whether liver function and blood clotting tests can help doctors better understand and monitor cardiac transthyretin amyloidosis (ATTR-CA), a condition where abnormal protein builds up in the heart. Researchers will compare these tests in people with ATTR-CA against those with another type of heart muscle disease. They will also check if these markers change after 6 and 12 months of treatment with tafamidis, a medication used for this condition. The goal is to find new tools for staging the disease and tracking its progression.

What this could mean

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

Active substance
Observational study with no intervention; evaluates tafamidis effects on liver and coagulation markers.
What this could lead to
If successful, this could lead to new markers for staging and tracking cardiac amyloidosis, improving patient monitoring and care.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may not change clinical practice without further validation.

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 70 people

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

Started

Jan 2026

Expected to finish

Jan 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

Adult patients with wild-type or hereditary transthyretin cardiac amyloidosis (ATTR-CA) followed at the University Hospital G. Martino, Messina, Italy, and an age-matched control population with non-amyloid hypertrophic phenotype cardiomyopathy.

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: * Written informed consent obtained prior to study participation. * Diagnosis of wild-type or hereditary transthyretin cardiac amyloidosis (ATTR-CA) according to current European recommendations. * Ability to comply with study procedures and follow-up visits. Exclusion Criteria: * Age younger than 18 years. * Severe liver dysfunction due to causes other than amyloidosis. * Inability to comply with study procedures because of language barriers, cognitive impairment, or severe psychiatric disorders. * Comorbidities associated with life expectancy less than 12 months. * Active alcohol or substance abuse. * For coagulation analyses: congenital coagulation disorders, thrombotic disorders, active malignancy, or sepsis. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial cardiomyopathy familial amyloid neuropathy heart failure liver disorder vascular hemostatic disease wild type ATTR amyloidosis

As listed by the trial registrant

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

Cardiac amyloidosis Cardiomyopathies Hereditary transthyretin amyloidosis (attrv) Transthyretin (TTR) amyloid cardiomyopathy Wild-type transthyretin 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

  • AOU Policlinico G. Martino, UOC Cardiologia con UTIC

    RECRUITING

    Messina, Sicily, 98124, Italy

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