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| Item Type: | Article |
|---|---|
| Title: | Protocol of the follow-up of patients with transthyretin amyloid cardiomyopathy by multimodality imaging (FAITH) study: a prospective observational study in patients with ATTR-CM undergoing treatment with tafamidis |
| Creators Name: | Gröschel, J., Barzen, G., Zernikow, J., Blaszczyk, E., Hahn, K., Pernice, H.F., Sack, I., Romero Dorta, E., van Dijck, P., Heidecker, B., Schwenke, C., Schulz-Menger, J. and Spethmann, S. |
| Abstract: | INTRODUCTION: This prospective observational study of patients with transthyretin amyloid cardiomyopathy (ATTR-CM) undergoing treatment with tafamidis aims at identifying quantitative image markers and comparing imaging modalities regarding the follow-up and prognostication of these patients, with the goal of providing a multiparametric score to predict treatment response. METHODS AND ANALYSIS: Patients with a board-approved decision to receive tafamidis will undergo, in addition to standard of care, baseline and follow-up cardiovascular magnetic resonance (CMR) scans at 9 and 18 months. In total, the study plans to recruit and scan 60 patients. A blinded read will take place in a CMR research core laboratory. The final statistical analysis will be based on developing a multiparametric score for the prediction of treatment response. The study will be managed through the Amyloidosis Center Charité Berlin, a clinical unit formed from the three clinical campus sites of the Charité in Berlin, using the Berlin Research Network for CMR. ETHICS AND DISSEMINATION: The study was approved by the Charité-Universitätsmedizin Berlin ethics committee EA1/262/23. The results of the study will be disseminated through international peer-reviewed publications and congress presentations. TRIAL REGISTRATION NUMBER: Approved WHO primary register: German Clinical Trials Register: https://www.drks.de/DRKS00033884. WHO International Clinical Registry Platform: https://trialsearch.who.int/?TrialID=DRKS00033884. Recruitment started on 1 July 2024. |
| Keywords: | Benzoxazoles, Cardiomyopathies, Familial Amyloid Neuropathies, Follow-Up Studies, Magnetic Resonance Imaging, Multimodal Imaging, Observational Studies As Topic, Prospective Studies |
| Source: | BMJ Open |
| ISSN: | 2044-6055 |
| Publisher: | BMJ Publishing Group |
| Volume: | 15 |
| Number: | 3 |
| Page Range: | e096397 |
| Date: | March 2025 |
| Official Publication: | https://doi.org/10.1136/bmjopen-2024-096397 |
| PubMed: | View item in PubMed |
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