An observational study in Transthyretin (TTR) Amyloid Cardiomyopathy, Cardiac Amyloidosis and Cardiomyopathies, sponsored by University of Messina. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University of Messina · Observational
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.
Transthyretin cardiac amyloidosis (ATTR-CA) is an increasingly recognized cause of heart failure and left ventricular hypertrophy in older adults. Although several prognostic models have been developed for ATTR-CA, most currently available staging systems are based primarily on cardiac biomarkers and renal function. These approaches may not fully capture the systemic nature of the disease.
Emerging evidence suggests that liver dysfunction and coagulation abnormalities may represent underexplored manifestations of ATTR-CA. Liver involvement may result from direct amyloid deposition, chronic venous congestion related to heart failure, or a combination of both mechanisms. Similarly, alterations in coagulation pathways may reflect hepatic dysfunction and systemic disease burden.
LICA2025 is a single-center, prospective, observational study designed to evaluate biochemical and instrumental markers of liver function and coagulation in patients with wild-type or hereditary ATTR-CA followed at the University Hospital G. Martino of Messina, Italy. A control population with non-amyloid hypertrophic cardiomyopathy will be enrolled for comparison.
The primary objective is to compare liver and coagulation parameters between ATTR-CA patients and controls. Secondary objectives include evaluating the relationship between hepatic/coagulation abnormalities and cardiac disease severity, assessing changes after 6±1 and 12±1 months of tafamidis therapy, and exploring potential interactions between liver dysfunction and coagulation disturbances.
Participants will undergo clinical evaluation, laboratory testing, electrocardiography, transthoracic echocardiography, hepatic ultrasound, liver elastography (FibroScan), and coagulation assessment according to the study protocol. Follow-up evaluations will be performed at baseline, 6 months, and 12 months.
The study aims to identify novel biomarkers and imaging parameters that may improve disease staging, risk stratification, and longitudinal monitoring in transthyretin cardiac amyloidosis.
82 studies on the registry are indexed under Amyloidosis, Hereditary, Transthyretin-Related; 28 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 40 observational studies indexed under Amyloidosis, Hereditary, Transthyretin-Related.
Browse Amyloidosis, Hereditary, Transthyretin-Related studies →University of Messina is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Compared within Amyloidosis, Hereditary, Transthyretin-Related, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Amyloid Neuropathies, Familial. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with wild-type or hereditary transthyretin cardiac amyloidosis (ATTR-CA) diagnosed according to current European recommendations and followed at the University Hospital G. Martino, Messina. Participants will undergo clinical, laboratory, echocardiographic, hepatic ultrasound, liver elastography, and coagulation assessments at baseline and during follow-up.
Age-matched patients with non-amyloid hypertrophic phenotype cardiomyopathy serving as a control population. Participants will undergo the same clinical, laboratory, echocardiographic, hepatic, and coagulation evaluations as the ATTR-CA group.
Liver Stiffness Measured by Transient Elastography (FibroScan)
Liver stiffness expressed in kilopascals (kPa) measured by transient elastography (FibroScan) in ATTR-CA patients and controls.
Time frame: Baseline, 6 Months, 12 Months
Controlled Attenuation Parameter (CAP) Measured by FibroScan
Controlled attenuation parameter (CAP) measured by FibroScan as an instrumental measure of hepatic steatosis, expressed in decibels per meter (dB/m), compared between patients with ATTR-CA and controls.
Time frame: Baseline, 6 months, 12 months
Serum Aspartate Aminotransferase (AST/GOT)
Serum AST/GOT concentration (U/L) measured by routine laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: Baseline, 6 months, 12 months
Serum Alanine Aminotransferase (ALT/GPT)
Serum ALT/GPT concentration (U/L) measured by routine laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Serum Gamma-Glutamyl Transferase (GGT)
Serum gamma-glutamyl transferase concentration (U/L) measured by routine laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Serum Alkaline Phosphatase (ALP)
Serum alkaline phosphatase concentration (U/L) measured by routine laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Serum Bile Acids
Serum bile acid concentration (mcmol/L) measured by laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Total Bilirubin (mg/dL)
Serum total bilirubin concentration measured by laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Direct Bilirubin (mg/dL)
Serum direct bilirubin concentration measured by laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Serum Albumin (g/dL)
Serum albumin concentration measured by laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Serum Gamma Globulins (g/dL)
Serum gamma-globulin concentration measured by laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Serum Immunoglobulin M (IgM) (g/L)
Serum IgM concentration measured by laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Serum Ferritin (ng/mL)
Serum ferritin concentration measured by laboratory testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Anti-Mitochondrial Antibodies
U/ml
Time frame: baseline, 6 months, 12 months
Fibrosis-4 (FIB-4) Index
FIB-4 index calculated from age, AST, ALT, and platelet count, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Portal Vein Diameter Assessed by Liver Ultrasound
Portal vein diameter (mm) measured by liver ultrasound, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Portal Vein Flow Velocity Assessed by Doppler Ultrasound (cm/s)
Portal vein blood flow velocity measured by Doppler ultrasound, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Spleen Diameter Assessed by Ultrasound (mm)
Spleen diameter measured by abdominal ultrasound, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Prothrombin Time (PT) (s)
Prothrombin time measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Activated Partial Thromboplastin Time (aPTT) (s)
Activated partial thromboplastin time measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
International Normalized Ratio (INR)
International normalized ratio (INR) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Plasma Fibrinogen
Plasma fibrinogen concentration (g/L) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Fibrin/Fibrinogen Degradation Products
Fibrin/fibrinogen degradation products concentration (mcg/Lm) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: Baseline, 6 months, 12 months
D-Dimer
D-dimer concentration (ng/mL) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Alpha-2-Antiplasmin
Alpha-2-antiplasmin concentration (UI/ml) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Antithrombin
Antithrombin concentration (IU) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Plasminogen
Plasminogen concentration (IU/ml) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Thrombin-Antithrombin Complex
Plasma fibrinogen concentration (ng/mL) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Plasmin-Alpha-2-Antiplasmin Complex
Plasmin-Alpha-2-Antiplasmin Complex concentration (ng/mL) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Prothrombin Fragment 1+2
Prothrombin Fragment 1+2 concentration (pmol/L) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Coagulation Factor X
Coagulation Factor X concentration (IU) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
von Willebrand Factor Antigen
von Willebrand Factor Antigen concentration (IU/mL) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Plasminogen Activator Inhibitor-1 (PAI-1)
Plasminogen Activator Inhibitor-1 concentration (U/mL) measured by standard laboratory coagulation testing, compared between patients with ATTR-CA and controls.
Time frame: baseline, 6 months, 12 months
Correlation Between Liver Stiffness (kPa) and NT-proBNP (ng/L)
Correlation between liver stiffness measured by FibroScan (kPa) and plasma NT-proBNP concentration (ng/L) in patients with ATTR-CA. Correlation will be assessed using Pearson or Spearman correlation coefficient, as appropriate.
Time frame: Baseline
Correlation Between Liver Stiffness and Interventricular Septal Thickness (mm)
Correlation between liver stiffness measured by FibroScan (kPa) and interventricular septal thickness expressed in mm measured by transthoracic echocardiography in patients with ATTR-CA. Correlation will be assessed using Pearson or Spearman correlation coefficient, as appropriate.
Time frame: Baseline
Correlation Between Liver Stiffness (kPa) and Left Ventricular Global Longitudinal Strain (GLS %)
Correlation between liver stiffness measured by FibroScan (kPa) and Global Longitudinal Strain (expressed in %) measured by transthoracic echocardiography in patients with ATTR-CA. Correlation will be assessed using Pearson or Spearman correlation coefficient, as appropriate.
Time frame: Baseline
Correlation Between Prothrombin Fragment 1+2 (pmol/L) and NT-proBNP (ng/L)
Correlation between Prothrombin Fragment 1+2 (pmol/L) and NT-proBNP (ng/L) measured by standard laboratory testing in patients with ATTR-CA. Correlation will be assessed using Pearson or Spearman correlation coefficient, as appropriate.
Time frame: Baseline
Change in Liver Stiffness During Disease-Modifying Treatment
Change in liver stiffness measured by FibroScan and expressed in kPa from baseline to 6±1 months and 12±1 months after treatment initiation.
Time frame: Baseline, 6±1 months, and 12±1 months
Change in Controlled Attenuation Parameter During Disease-Modifying Treatment
Change in controlled attenuation parameter (CAP) measured by FibroScan and expressed in dB/m from baseline to 6±1 months and 12±1 months after treatment initiation.
Time frame: Baseline, 6±1 months, and 12±1 months
Correlation Between Liver Stiffness and Prothrombin Fragment 1+2
Correlation between liver stiffness measured by transient elastography (FibroScan), expressed in kPa, and plasma prothrombin fragment 1+2 concentration in patients with ATTR-CA. Correlation will be assessed using Pearson or Spearman correlation coefficient, as appropriate.
Time frame: Baseline
Correlation Between FIB-4 Index and Prothrombin Fragment 1+2
Correlation between FIB-4 and plasma prothrombin fragment 1+2 concentration in patients with ATTR-CA. Correlation will be assessed using Pearson or Spearman correlation coefficient, as appropriate.
Time frame: Baseline
Correlation Between Liver Stiffness and Fibrinogen
Correlation between liver stiffness measured by transient elastography (FibroScan), expressed in kPa, and plasma fibrinogen concentration in patients with ATTR-CA. Correlation will be assessed using Pearson or Spearman correlation coefficient, as appropriate.
Time frame: Baseline
Plan to share: Undecided — The decision regarding IPD sharing has not yet been finalized. Any future data sharing will be considered in accordance with applicable ethical approvals, participant consent, institutional policies, and data protection regulations.
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Amyloidosis, Hereditary, Transthyretin-Related →
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