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Cardiac Amyloidosis / Transthyretin (TTR) Amyloid Cardiomyopathy / Cardiomyopathies · Observational Study
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective observational study registration investigating liver stiffness, liver function, and coagulation parameters in patients with cardiac transthyretin amyloidosis compared to age-matched controls. No results are yet reported in this registry record. The study aims to evaluate whether these parameters serve as markers of disease severity and progression, with assessments at baseline, 6 months, and 12 months, including a treatment phase with tafamidis.
Observational. Transthyretin (TTR) Amyloid Cardiomyopathy, Cardiac Amyloidosis, Cardiomyopathies, Wild-Type Transthyretin Cardiac Amyloidosis, Hereditary Transthyretin Amyloi…; age from 18 Years. Intervention: ATTR-CA Patients; Hypertrophic Phenotype Controls. Compared with: Age-matched control population with non-amyloid hypertrophic cardiomyopathy.. n = 70. 1 site: Italy.
This is a prospective observational study registration investigating liver stiffness, liver function, and coagulation parameters in patients with cardiac transthyretin amyloidosis compared to age-matched controls. No results are yet reported in this registry record. The study aims to evaluate whether these parameters serve as markers of disease severity and progression, with assessments at baseline, 6 months, and 12 months, including a treatment phase with tafamidis.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Once results are posted, this observational study may identify novel hepatic and coagulation biomarkers for disease staging and monitoring in ATTR-CA; clinicians should await outcome data before integrating these parameters into practice.
This is a prospective observational registry record with no posted results; it describes planned enrollment and outcome measures for a study investigating liver and coagulation dysfunction in cardiac transthyretin amyloidosis.
As stated by the source record.
Quoted from the source exactly as published.
Once results are posted, this observational study may identify novel hepatic and coagulation biomarkers for disease staging and monitoring in ATTR-CA; clinicians should await outcome data before integrating these parameters into practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07766135). This is a study registration, not published results. Lead sponsor: University of Messina. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 70 participants (ESTIMATED). Conditions: Transthyretin (TTR) Amyloid Cardiomyopathy, Cardiac Amyloidosis, Cardiomyopathies, Wild-Type Transthyretin Cardiac Amyloidosis, Hereditary Transthyretin Amyloidosis (ATTRv). Primary outcome measures: Liver Stiffness Measured by Transient Elastography (FibroScan) , Baseline, 6 Months, 12 Months; Controlled Attenuation Parameter (CAP) Measured by FibroScan , Baseline, 6 months, 12 months; Serum Aspartate Aminotransferase (AST/GOT) , Baseline, 6 months, 12 months; Serum Alanine Aminotransferase (ALT/GPT) , baseline, 6 months, 12 months; Serum Gamma-Glutamyl Transferase (GGT) , baseline, 6 months, 12 months; Serum Alkaline Phosphatase (ALP) , baseline, 6 months, 12 months; Serum Bile Acids , baseline, 6 months, 12 months; Total Bilirubin (mg/dL) , baseline, 6 months, 12 months; Direct Bilirubin (mg/dL) , baseline, 6 months, 12 months; Serum Albumin (g/dL) , baseline, 6 months, 12 months; Serum Gamma Globulins (g/dL) , baseline, 6 months, 12 months; Serum Immunoglobulin M (IgM) (g/L) , baseline, 6 months, 12 months; Serum Ferritin (ng/mL) , baseline, 6 months, 12 months; Anti-Mitochondrial Antibodies , baseline, 6 months, 12 months; Fibrosis-4 (FIB-4) Index , baseline, 6 months, 12 months; Portal Vein Diameter Assessed by Liver Ultrasound , baseline, 6 months, 12 months; Portal Vein Flow Velocity Assessed by Doppler Ultrasound (cm/s) , baseline, 6 months, 12 months; Spleen Diameter Assessed by Ultrasound (mm) , baseline, 6 months, 12 months; Prothrombin Time (PT) (s) , baseline, 6 months, 12 months; Activated Partial Thromboplastin Time (aPTT) (s) , baseline, 6 months, 12 months; International Normalized Ratio (INR) , baseline, 6 months, 12 months; Plasma Fibrinogen , baseline, 6 months, 12 months; Fibrin/Fibrinogen Degradation Products , Baseline, 6 months, 12 months; D-Dimer , baseline, 6 months, 12 months; Alpha-2-Antiplasmin , baseline, 6 months, 12 months; Antithrombin , baseline, 6 months, 12 months; Plasminogen , baseline, 6 months, 12 months; Thrombin-Antithrombin Complex , baseline, 6 months, 12 months; Plasmin-Alpha-2-Antiplasmin Complex , baseline, 6 months, 12 months; Prothrombin Fragment 1+2 , baseline, 6 months, 12 months; Coagulation Factor X , baseline, 6 months, 12 months; von Willebrand Factor Antigen , baseline, 6 months, 12 months; Plasminogen Activator Inhibitor-1 (PAI-1) , baseline, 6 months, 12 months. Brief 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.
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