Liver and Coagulation Markers in ATTR Cardiac Amyloidosis
Official title: Liver and Coagulation Disorders in Cardiac Transthyretin Amyloidosis (ATTR-CA): New Horizons in Disease Staging and Follow-Up
Run by University of Messina · NCT07766135 · Data updated 2026-11-12
This study tests liver function and blood-clotting markers in people with ATTR-CA to see if they reflect disease severity and progression.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | University of Messina Academic / other |
| Locations | 1 site (Messina, Sicily) |
| Status | Recruiting |
| Started | January 30, 2026 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT07766135 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with either wild-type or hereditary transthyretin cardiac amyloidosis who can comply with follow-up and participate in serial assessments.
✕Probably not a fit
Patients with non-amyloid cardiomyopathy or those unable to complete follow-up may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study at the University Hospital G. Martino in Messina, Italy. It aims to measure biochemical and imaging markers of liver function and coagulation in patients with wild-type or hereditary ATTR-CA and compare them to an age-matched control group with non-amyloid hypertrophic cardiomyopathy. Participants are followed over about 6 to 12 months, with assessments at baseline, around 6 months, and around 12 months, including hepatic ultrasound and liver stiffness alongside standard cardiac evaluations. The study also explores how these liver and coagulation parameters relate to cardiac disease severity and changes with tafamidis therapy. Interventions are not prescribed by the protocol; observations are collected during routine care.
Why it matters
Potential benefit: If successful, liver and coagulation markers could provide additional prognostic information and guide management in ATTR-CA patients.
How similar studies have gone: Prior work suggests systemic manifestations in ATTR-CA; this study seeks to extend those observations with standardized measurements of liver and coagulation parameters.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
AOU Policlinico G. Martino, UOC Cardiologia con UTIC
Messina, Sicily, Italy Recruiting
Study contacts
- Principal investigator: Luigi Colarusso, MD, PhD Candidate — AOU Policlinico G. Martino
- Study coordinator: Luigi Colarusso, MD, PhD Candidate
- Email: luigi.colarusso@polime.it
- Phone: +390902212341
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Study of heart conditions using advanced imaging techniques
This study is trying to find out what causes different heart conditions in Hispanic and African American people in the Bronx by using advanced imaging techniques.
-
Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS
Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.
-
Cardiac Amyloidosis: See if Intracardiac Thrombi are Common on CT
This study tests whether a contrast-enhanced cardiac CT can reliably detect intracardiac thrombi in adults with cardiac amyloidosis.
-
Higher pacemaker rate for people with cardiac amyloidosis
This study will see if temporarily increasing the pacemaker rate improves heart-failure symptoms and exercise tolerance in adults with cardiac amyloidosis who already have pacemakers.
-
Using [64Cu]FBP8 PET/MR to find intracardiac blood clots in cardiac amyloidosis
We'll test whether a [64Cu]FBP8 PET/MR scan can find blood clots inside the heart of people with cardiac amyloidosis who have atrial fibrillation or atrial flutter.
-
RHYthm and Myocardial Function Relationship in Heart Disease
This study tests how heart rhythm patterns relate to heart muscle function in adults with arrhythmias or cardiomyopathy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.