NCT07766135Recruiting
Liver and Coagulation Disorders in Cardiac Transthyretin Amyloidosis
Liver and Coagulation Disorders in Cardiac Transthyretin Amyloidosis (ATTR-CA): New Horizons in Disease Staging and Follow-Up
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 12 Jun 2026
- Start date
- 30 Jan 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- University of Messina
- Diseases
- Amyloidosis, Heart failure
- NCT number
- NCT07766135
What you commit to
- Study type: Observational
- Planned participants: 70
- From 30 Jan 2026 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to comply with study procedures because of language barriers, cognitive impairment, or severe psychiatric disorders.
- For coagulation analyses: congenital coagulation disorders, thrombotic disorders, active malignancy, or sepsis.
Age
- Age younger than 18 years.
Other
- Severe liver dysfunction due to causes other than amyloidosis.
- Comorbidities associated with life expectancy less than 12 months.
- Active alcohol or substance abuse.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AOU Policlinico G. Martino, UOC Cardiologia con UTIC Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.