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Liver and Coagulation Disorders in Cardiac Transthyretin Amyloidosis

NCT07766135 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

  • Transthyretin (TTR) Amyloid Cardiomyopathy
  • Cardiac Amyloidosis
  • Cardiomyopathies
  • Wild-Type Transthyretin Cardiac Amyloidosis
  • Hereditary Transthyretin Amyloidosis (ATTRv)

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"

    collaborator OTHER

  • University of Messina

    lead OTHER

Principal Investigators

  • Gianluca Di Bella, MD, PhD · University of Messina and AOU Policlinico G. Martino

  • Luigi Colarusso, MD, PhD Candidate · AOU Policlinico G. Martino

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766135 on ClinicalTrials.gov