RecruitingNot Applicable

Liver and Coagulation Disorders in Cardiac Transthyretin Amyloidosis

Italy70 participantsStarted 2026-01-30

Plain-language summary

Transthyretin cardiac amyloidosis (ATTR-CA) is a progressive infiltrative cardiomyopathy caused by the deposition of misfolded transthyretin protein within the myocardium. Current disease staging and follow-up strategies mainly rely on cardiac biomarkers and renal function; however, the systemic nature of ATTR suggests that additional organ involvement may provide valuable prognostic information. The purpose of this prospective observational study is to investigate liver dysfunction and coagulation abnormalities in patients with wild-type or hereditary ATTR-CA and to evaluate their potential role as novel markers of disease severity and progression. Patients with ATTR-CA will be compared with an age-matched control population with non-amyloid hypertrophic cardiomyopathy. Clinical, laboratory, echocardiographic, hepatic ultrasound, liver stiffness, and coagulation parameters will be assessed at baseline and during follow-up. The study will also evaluate changes in these parameters after 6 and 12 months of treatment with tafamidis. The results may improve the understanding of cardio-hepatic interactions in ATTR-CA and identify new tools for disease staging and longitudinal monitoring.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Liver Stiffness Measured by Transient Elastography (FibroScan)

Timeframe: Baseline, 6 Months, 12 Months

Controlled Attenuation Parameter (CAP) Measured by FibroScan

Timeframe: Baseline, 6 months, 12 months

Serum Aspartate Aminotransferase (AST/GOT)

Timeframe: Baseline, 6 months, 12 months

Serum Alanine Aminotransferase (ALT/GPT)

Timeframe: baseline, 6 months, 12 months

Serum Gamma-Glutamyl Transferase (GGT)

Timeframe: baseline, 6 months, 12 months

Serum Alkaline Phosphatase (ALP)

Timeframe: baseline, 6 months, 12 months

Serum Bile Acids

Timeframe: baseline, 6 months, 12 months

Trial details

NCT IDNCT07766135

SponsorUniversity of Messina

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-01

Contact for this trial

Luigi Colarusso, MD, PhD Candidate

+390902212341 luigi.colarusso@polime.it

View on ClinicalTrials.gov More Transthyretin (TTR) Amyloid Cardiomyopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Liver Stiffness Measured by Transient Elastography (FibroScan)

Timeframe: Baseline, 6 Months, 12 Months

Controlled Attenuation Parameter (CAP) Measured by FibroScan

Timeframe: Baseline, 6 months, 12 months

Serum Aspartate Aminotransferase (AST/GOT)

Timeframe: Baseline, 6 months, 12 months

Serum Alanine Aminotransferase (ALT/GPT)

Timeframe: baseline, 6 months, 12 months

Serum Gamma-Glutamyl Transferase (GGT)

Timeframe: baseline, 6 months, 12 months

Serum Alkaline Phosphatase (ALP)

Timeframe: baseline, 6 months, 12 months

Serum Bile Acids

Timeframe: baseline, 6 months, 12 months