PET, MRI and ultrasound to track heart changes in ATTR cardiac amyloidosis
Natural History of Cardiac Transthyretin Amyloidosis - Mechanistic Insights by Multimodality Imaging
This study will try PET, MRI and ultrasound scans in people with ATTR cardiac amyloidosis starting tafamidis to see if the new images explain why some patients keep getting worse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT07112066 on ClinicalTrials.gov |
What this trial studies
This open-label, prospective longitudinal study will enroll 50 people with cardiac ATTR amyloidosis who are about to start tafamidis and perform serial imaging at baseline and after 12 months. Participants will have cardiac ultrasound, cardiac MRI, and cardiac PET with an 18F-FAPI tracer, along with blood tests (including NT-proBNP, troponin and BMP4) and functional assessments (NYHA class, KCCQ, 6‑minute walk). Conventional clinical, laboratory and imaging markers will be collected during routine follow-up to classify progression (expected in ~30%) and to compare with novel imaging signals. Patients on other disease-modifying therapies or with ongoing supraventricular arrhythmia, ventricular pacing, or prior septal myocardial infarction are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults with confirmed cardiac ATTR amyloidosis who are about to start tafamidis at the University Hospital Zurich and meet the study exclusion criteria.
Not a fit: Patients already receiving other disease-modifying therapies, those with ongoing supraventricular arrhythmia, ventricular pacing, prior septal myocardial infarction, or those unable to attend baseline and 12‑month imaging are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could identify imaging or blood markers that detect early progression and help personalize treatment for people with ATTR cardiac amyloidosis.
How similar studies have performed: While MRI and conventional echocardiography are established in ATTR, use of 18F-FAPI PET and serum BMP4 for tracking disease progression is novel and has limited prior clinical validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with cardiac ATTR amyloidosis, as recently defined by multi-societal criteria, who are about to start tafamidis at the University Hospital Zurich Exclusion Criteria: * Any other disease-modifying therapy (e.g. patisiran) * Ongoing supraventricular arrhythmia * Ventricular pacing * Prior septal myocardial infarction
Where this trial is running
Zurich, Canton of Zurich
- University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Dominik C Benz, MD — Universität Zürich
- Study coordinator: Dominik C Benz, PD Dr. med.
- Email: dominik.benz@usz.ch
- Phone: +41432531191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.