Actively Recruiting
Natural History of Cardiac Transthyretin Amyloidosis Using Multimodality Imaging for Mechanistic Insights
Led by Dominik Benz · Updated on 2025-12-09
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Dominik Benz
Lead Sponsor
O
Olga Mayenfisch Stiftung, Zurich, Switzerland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether new imaging techniques can improve understanding of cardiac amyloidosis, a condition where the disease progresses despite treatment in about one-third of patients. The study aims to learn more about the biological changes in the heart muscle and why treatment is not effective for all patients. This open-label, prospective study involves 50 participants diagnosed with cardiac transthyretin amyloidosis (ATTR-CM) following recent multi-societal criteria. Participants will undergo additional imaging tests, including heart ultrasound, cardiac MRI, and cardiac PET scans using a FAPI tracer, at the start of the study and after one year. Blood samples will be collected for BMP4 serum concentration analysis. These tests are designed to monitor changes over time, with a focus on myocardial stiffness and other markers. The study includes clinical, functional, laboratory, and imaging evaluations to track disease progression. During the study, participants will have heart ultrasound, cardiac MRI, and PET scans taking from 5 to 10 minutes for ultrasound and about 2 hours each for MRI and PET. Questionnaires will also be completed at baseline. Researchers will measure changes in FAPI uptake, myocardial stiffness, extracellular volume, and BMP4 expression over 12 months. Safety and clinical status will be monitored through hospital records, walk tests, and heart function questionnaires. The study duration is one year with two main assessment visits.
CONDITIONS
Brief Title
Multimodality Cardiac Imaging for Disease Progression in ATTR-CM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with cardiac ATTR amyloidosis as defined by recent multi-societal criteria
- Participants about to start tafamidis treatment at the University Hospital Zurich
You will not qualify if you...
- Use of any other disease-modifying therapy such as patisiran
- Presence of ongoing supraventricular arrhythmia
- Having ventricular pacing
- History of prior septal myocardial infarction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline cardiac imaging and blood sample collection to assess disease status before starting tafamidis treatment.
1 baseline visit (in-person)
Duration - 12 months
Participants receive tafamidis treatment and are monitored with routine clinical follow-up and repeat imaging and blood sampling after 12 months to assess disease progression.
1 follow-up visit at 12 months (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
D
Dominik C Benz, PD Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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