ClinicalTrials.gov record NCT07112066

Multimodality Cardiac Imaging for Disease Progression in ATTR-CM

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Natural History of Cardiac Transthyretin Amyloidosis - Mechanistic Insights by Multimodality Imaging

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
SexAll
LocationSwitzerland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This diagnostic study tests whether newer heart imaging methods and blood markers help describe disease course in cardiac ATTR amyloidosis. It enrolls people with cardiac ATTR amyloidosis who are about to start tafamidis. All participants receive extra cardiac ultrasound, cardiac MRI, cardiac PET (18F-FAPI), and blood sampling at the start and again after 12 months.

What it is studying. Whether multimodality imaging (18F-FAPI PET, MRI, echocardiography) and blood markers (including BMP4) reveal biological changes and track disease progression in cardiac ATTR amyloidosis.

What the researchers hope to learn. To learn whether FAPI PET uptake, echocardiographic myocardial stiffness, MRI measures (extracellular volume), and BMP4 levels change with disease progression. To explore links between these imaging and blood markers and conventional clinical, laboratory, and functional measures of cardiac amyloidosis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • FAPI tracer

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants undergo additional testing at study start and again at 12 months: an echocardiogram (~5–10 minutes), a cardiac MRI (about 2 hours), and a cardiac PET/CT (about 2 hours) that includes an intravenous injection of the F‑FAPI‑74 tracer and imaging about 60 minutes later. Blood samples are taken during routine clinical visits and participants complete short questionnaires. In a subgroup of about 10 people, endomyocardial biopsy tissue obtained as part of routine clinical care may be analyzed for research.

How the study is structured. Single-group, open-label diagnostic study. All participants have the same additional tests (echocardiogram, cardiac MRI, cardiac PET, and blood samples) at baseline and again at 12 months to look for changes over time.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Switzerland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 20, 2025
Primary completion
June 2027 (estimated)
Study completion
June 2027 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Dec 9, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Dominik Benz
Collaborators
  • Olga Mayenfisch Stiftung, Zurich, Switzerland
  • University of Zurich

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
open label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
6-minute walk test
A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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