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.

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.