Amyloidosis CardiacFAPI-ATTRNCT07112066
Multimodality Cardiac Imaging for Disease Progression in ATTR-CM
A study testing FAPI tracer in people with Amyloidosis Cardiac, run by Dominik Benz at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to investigate whether new imaging techniques can help us to better understand the cardiac amyloidosis. The disease can be slowed down with various medications (e.g., tafamidis, acoramidis, or vutrisiran). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyloidosis Cardiac
- What is being tested?
- FAPI tracer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Oct 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with cardiac ATTR amyloidosis, as recently defined by multi-societal criteria, who are about to start tafamidis at the University Hospital Zurich
Who cannot join
- Any other disease-modifying therapy (e.g. patisiran)
- Ongoing supraventricular arrhythmia
- Ventricular pacing
- Prior septal myocardial infarction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Dominik Benz, PD Dr. med., +41 43 253 11 91, dominik.benz@usz.ch
Mirjam Marty, MSc in Nursing, +41442552827, mirjam.marty@usz.ch
About this study
Official title: Natural History of Cardiac Transthyretin Amyloidosis - Mechanistic Insights by Multimodality Imaging
The goal of this clinical trial is to investigate whether new imaging techniques can help us to better understand the cardiac amyloidosis. The disease can be slowed down with various medications (e.g., tafamidis, acoramidis, or vutrisiran). However, treatment is not effective in all patients-in about one-third of cases, the disease continues to progress. So far, we know little about the exact causes of this and what biological changes occur in the heart muscle.
The main question it aims to answer is:
Read more
Will new imaging techniques help us understand the course of the cardiac amyloidosis?
Participants will have additional examinations:
- At the beginning of the study: one additional heart ultrasound examination, one cardiac MRI and one cardiac PET, blood examination during the regular examination, questionnaires.
- After a year: one additional heart ultrasound examination, one cardiac MRI and one cardiac PET, blood examination during the regular examination.
Time required:
- Heart ultrasound examination: 5-10 Minutes
- Cardiac MRI: 2 hours
- Cardiac PET: 2 hours
- Questionnaires: 5-10 Minutes.
Read the detailed description
Experimental Design The study design is an open label prospective longitudinal study with serial imaging at baseline and after 12-month follow-up. The entire study population will include 50 participants with cardiac ATTR amyloidosis, as recently defined by multi-societal criteria.
Conventional markers of disease progression
These markers are collected during routine clinical follow-up of patients in our Outpatient Clinic. The markers are divided into three domains and include the following outcomes:
- Clinical and functional: any heart failure hospitalization, NYHA class, Kansas City Cardiomyopathy Questionnaire, 6-minute walk test;
- Laboratory biomarkers: NT-proBNP, troponin, creatinine;
- Imaging and ECG: LV wall thickness, diastolic dysfunction, LVEF, stroke volume, global longitudinal strain, conduction disturbance.
Data Analysis Plan Power calculation for sample size is challenging as no previous study has evaluated the response of our endpoints in myocardial FAPI uptake or serum BMP4 concentration to tafamidis. We therefore focused sample size calculation of echocardiographic myocardial stiffness. Based on our own preliminary data, we estimate median baseline values for myocardial stiffness of 2.6 m/s [IQR, 1.7-3.8] in cardiac amyloidosis. Disease progression is expected in about 30% of participants. While myocardial stiffness is expected to remain unchanged in cardiac amyloidosis without disease progression a 20% relative increase (i.e. 0.5 ± 0.5 m/s) is considered in cardiac amyloidosis with disease progression. A sample size of 40 participants (i.e. 30 participants without and 10 participants with disease progression) has a statistical power of 80% to predict a difference in response of myocardial stiffness to tafamidis.
Non-normally distributed, paired data of repeated measures (i.e. longitudinal changes per group) are compared by Wilcoxon signed rank test. Non-normally distributed unpaired data of changes (i.e. longitudinal changes between groups) are compared by Mann-Whitney test. The correlations are compared by a z-test on Fisher z-transformed correlation coefficients.
- Conditions
- Amyloidosis Cardiac
- Being tested
- FAPI tracer
- Keywords
- cardiac ATTR amyloidosis, BMP4 protein, human, 18F-FAPI-74, PET, CT
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI tracerDiagnostic test
18F-FAPI-74 PET/CT, cardiac MRI, echocardiography and blood sample for BMP5 serum concetration is performed at baseline and 12-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FAPI PET/CT | Experimental | Additional imaging including 18F-FAPI PET/CT is performed Receives: Diagnostic Test: FAPI tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FAPI uptake
F-FAPI-74 PET/CT is performed at baseline and 12-month follow-up. Images are acquired on a PET/CT scanner 60 minutes after intravenous injection of F-FAPI-74. The emission scan is obtained from the apex of the lung to the base of the lung. One bed position is acquired (20 minutes, 3-dimensional mode), and the heart is set at the center of the view. Myocardial F-FAPI-74 uptake is quantified by the mean standardized uptakte value of the LV volume of interest (VOI). The epicardial LV contour is drawn on the CT scan and, to correct for blood pool activity, the endocardial border is defined automatically by thresholding for 2 times the mean SUV of the blood pool.
Measured: Baseline and 1 year
Secondary outcomes (3)
Change in echocardiographic myocardial stiffness
Cardiac intrinsic elastography from echocardiography is performed at baseline and at 12-month follow-up. Ultrahigh-frame rate tissue Doppler data (>250 frames/sec) are acquired using clinical scanners from the apical fourchamber view while carefully aligning the septal wall with the Doppler beam. The base-to-apex propagation of the late diastolic myocardial stretch wave can be visualized with ultrafast imaging data. The slope of the isovelocity wave front, called intrinsic velocity propagation (iVP) of myocardial stretch (in meters per second) is measured offline. By averaging values for three cardiac cycles, a global value is generated.
Measured: Baseline and 1 year
Change in extracellular volume (ECV)
Cardiac MRI is performed at baseline and 12-month follow-up. Myocardial LV native T1 maps are acquired in 3 short-axis slices at the base, mid and apical levels using the modified Look-Locker inversion (MOLLI) recovery technique at end-diastole for 3 cycles (5-3-1 R-R durations with 3-4 R-R rest periods) during a single breath hold. T1 mapping is repeated with the same settings 10 minutes after intravenous administration of 0.1 mmol/kg of gadolinium contrast agent. The ECV fraction is estimated by plotting the reciprocal of each segmental myocardial T1 against the reciprocal of the blood pool T1 for native, 10-minute post-contrast MOLLI acquisitions, then calculating linear regression slopes, corresponding to segmental partition coefficients for gadolinium (λGd). Each λGd was multiplied by (1 - hematocrit) to obtain ECV fractions.
Measured: Baseline and 1 year
Change in BMP4 expression and serum concentration
Serum samples are analyzed. BMP4 levels in the samples were measured using a human BMP4 SimpleStep ELISA Kit following manufacturer's instructions.
Endomyocardial biopsies as part of the clinical diagnostic routine from the subgroup of 10 participants with suspicion of cardiac ATTR amyloidosis are analyzed. Cardiac tissue is fixed in 4% formaladehyde and embedded in paraffin. Histopathological changes are evaluated after H\&E staining and the area of percentage of collagen networks per section is determined. For the assessment of BMP4 mRNA expression in tissue, homogenates are generated, samples are centrifuged and the supernatant is used for ELISA measurements.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start20 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloidosis CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominik Benz
- Sponsor type
- University, hospital or other
- Collaborators
- Olga Mayenfisch Stiftung, Zurich, Switzerland, University of Zurich
- Responsible party
- Sponsor-investigator, Dominik Benz, University of Zurich
- Investigators
- Dominik C Benz, MD, Principal investigator, Universität Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112066
- Sponsor's protocol ID
- 2024-02504
- Acronym
- FAPI-ATTR
- Status last verified
- Dec 2025
- First submitted
- 14 Jul 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Cardiac Transthyretin Amyloidosis - Mechanistic Insights by Multimodality Imaging
- ClinicalTrials.gov ID
- NCT07112066
- Acronym / sponsor ID
- FAPI-ATTR / 2024-02504
- Conditions
- Amyloidosis Cardiac
- Keywords
- cardiac ATTR amyloidosis, BMP4 protein, human, 18F-FAPI-74, PET, CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dominik BenzUniversity, hospital or other
- Collaborators
- Olga Mayenfisch Stiftung, Zurich, Switzerland, University of Zurich
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate whether new imaging techniques can help us to better understand the cardiac amyloidosis. The disease can be slowed down with various medications (e.g., tafamidis, acoramidis, or vutrisiran). However, treatment is not effective in all patients-in about one-third of cases, the disease continues to progress. So far, we know little about the exact causes of this and what biological changes occur in the heart muscle.
The main question it aims to answer is:
Will new imaging techniques help us understand the course of the cardiac amyloidosis?
Participants will have additional examinations:
- At the beginning of the study: one additional heart ultrasound examination, one cardiac MRI and one cardiac PET, blood examination during the regular examination, questionnaires.
- After a year: one additional heart ultrasound examination, one cardiac MRI and one cardiac PET, blood examination during the regular examination.
Time required:
- Heart ultrasound examination: 5-10 Minutes
- Cardiac MRI: 2 hours
- Cardiac PET: 2 hours
- Questionnaires: 5-10 Minutes.
Detailed description
Experimental Design The study design is an open label prospective longitudinal study with serial imaging at baseline and after 12-month follow-up. The entire study population will include 50 participants with cardiac ATTR amyloidosis, as recently defined by multi-societal criteria.
Conventional markers of disease progression
These markers are collected during routine clinical follow-up of patients in our Outpatient Clinic. The markers are divided into three domains and include the following outcomes:
- Clinical and functional: any heart failure hospitalization, NYHA class, Kansas City Cardiomyopathy Questionnaire, 6-minute walk test;
- Laboratory biomarkers: NT-proBNP, troponin, creatinine;
- Imaging and ECG: LV wall thickness, diastolic dysfunction, LVEF, stroke volume, global longitudinal strain, conduction disturbance.
Data Analysis Plan Power calculation for sample size is challenging as no previous study has evaluated the response of our endpoints in myocardial FAPI uptake or serum BMP4 concentration to tafamidis. We therefore focused sample size calculation of echocardiographic myocardial stiffness. Based on our own preliminary data, we estimate median baseline values for myocardial stiffness of 2.6 m/s [IQR, 1.7-3.8] in cardiac amyloidosis. Disease progression is expected in about 30% of participants. While myocardial stiffness is expected to remain unchanged in cardiac amyloidosis without disease progression a 20% relative increase (i.e. 0.5 ± 0.5 m/s) is considered in cardiac amyloidosis with disease progression. A sample size of 40 participants (i.e. 30 participants without and 10 participants with disease progression) has a statistical power of 80% to predict a difference in response of myocardial stiffness to tafamidis.
Non-normally distributed, paired data of repeated measures (i.e. longitudinal changes per group) are compared by Wilcoxon signed rank test. Non-normally distributed unpaired data of changes (i.e. longitudinal changes between groups) are compared by Mann-Whitney test. The correlations are compared by a z-test on Fisher z-transformed correlation coefficients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FAPI PET/CT | Experimental | Diagnostic Test: FAPI tracerAdditional imaging including 18F-FAPI PET/CT is performed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with cardiac ATTR amyloidosis, as recently defined by multi-societal criteria, who are about to start tafamidis at the University Hospital Zurich
Key exclusion criteria (4 listed)
- Any other disease-modifying therapy (e.g. patisiran)
- Ongoing supraventricular arrhythmia
- Ventricular pacing
- Prior septal myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAPI tracer18F-FAPI-74 PET/CT, cardiac MRI, echocardiography and blood sample for BMP5 serum concetration is performed at baseline and 12-month follow-up. | Diagnostic test | 18F-FAPI PET/CT |
Primary outcome
Change in FAPI uptake
Time frame: Baseline and 1 year
F-FAPI-74 PET/CT is performed at baseline and 12-month follow-up. Images are acquired on a PET/CT scanner 60 minutes after intravenous injection of F-FAPI-74. The emission scan is obtained from the apex of the lung to the base of the lung. One bed position is acquired (20 minutes, 3-dimensional mode), and the heart is set at the center of the view. Myocardial F-FAPI-74 uptake is quantified by the mean standardized uptakte value of the LV volume of interest (VOI). The epicardial LV contour is drawn on the CT scan and, to correct for blood pool activity, the endocardial border is defined automatically by thresholding for 2 times the mean SUV of the blood pool.
3 secondary outcomes
Change in echocardiographic myocardial stiffness
Time frame: Baseline and 1 year
Change in extracellular volume (ECV)
Time frame: Baseline and 1 year
Change in BMP4 expression and serum concentration
Time frame: Baseline and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominik C Benz, MD principal investigator
Universität Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAPI tracer in people with Amyloidosis Cardiac, run by Dominik Benz at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominik C Benz, PD Dr. med. (+41432531191, dominik.benz@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FAPI uptake (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.