Multimodality Cardiac Imaging for Disease Progression in ATTR-CM

NCT07112066 | Recruiting

• 1 other identifier: 2024-02504
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Amyloidosis Cardiac

Keywords

cardiac ATTR amyloidosis; BMP4 protein, human; 18F-FAPI-74; PET; CT

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 1 year

Secondary Outcomes (3)

• Change in echocardiographic myocardial stiffness

  Baseline and 1 year

• Change in extracellular volume (ECV)

  Baseline and 1 year

• Change in BMP4 expression and serum concentration

  Baseline and 1 year

Study Arms (1)

18F-FAPI PET/CT

EXPERIMENTAL

Additional imaging including 18F-FAPI PET/CT is performed

Diagnostic Test: FAPI tracer

Interventions

FAPI tracer DIAGNOSTIC_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.

18F-FAPI PET/CT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with cardiac ATTR amyloidosis, as recently defined by multi-societal criteria, who are about to start tafamidis at the University Hospital Zurich

You may not qualify if:

• Any other disease-modifying therapy (e.g. patisiran)
• Ongoing supraventricular arrhythmia
• Ventricular pacing
• Prior septal myocardial infarction

Sponsors & Collaborators

• Dominik Benz: lead
• Olga Mayenfisch Stiftung, Zurich, Switzerland: collaborator
• University of Zurich: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Dominik C Benz, MD

  Universität Zürich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik C Benz, PD Dr. med.

CONTACT

+41432531191; dominik.benz@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med. Dominik C. Benz

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 8, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)