The Cardiac Amyloidosis Registry Study (CARS): Rationale, Design and Methodology

J Card Fail. 2024 May;30(5):669-678. doi: 10.1016/j.cardfail.2023.09.016. Epub 2023 Oct 30.

Abstract

Background: CARS (Cardiac Amyloidosis Registry Study) is a multicenter registry established in 2019 that includes patients with transthyretin (ATTR, wild-type and variant) and light chain (AL) cardiac amyloidosis (CA) evaluated at major amyloidosis centers between 1997 and 2025. CARS aims to describe the natural history of CA with attention to clinical and diagnostic variables at the time of diagnosis, real-world treatment patterns, and associated outcomes of patients in a diverse cohort that is more representative of the at-risk population than that described in CA clinical trials.

Methods and results: This article describes the design and methodology of CARS, including procedures for data collection and preliminary results. As of February 2023, 20 centers in the United States enrolled 1415 patients, including 1155 (82%) with ATTR and 260 (18%) with AL CA. Among those with ATTR, wild-type is the most common ATTR (71%), and most of the 305 patients with variant ATTR have the p.V142I mutation (68%). A quarter of the total population identifies as Black. More individuals with AL are female (39%) compared to those with ATTR (13%).

Conclusions: CARS will answer crucial clinical questions about CA natural history and permit comparison of different therapeutics not possible through current clinical trials. Future international collaboration will further strengthen the validity of observations of this increasingly recognized condition.

Keywords: Cardiac amyloidosis; light chain amyloidosis; registry; transthyretin amyloidosis.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Amyloid Neuropathies, Familial / diagnosis
  • Amyloid Neuropathies, Familial / epidemiology
  • Amyloid Neuropathies, Familial / genetics
  • Amyloid Neuropathies, Familial / therapy
  • Amyloidosis / diagnosis
  • Amyloidosis / epidemiology
  • Amyloidosis / therapy
  • Cardiomyopathies / diagnosis
  • Cardiomyopathies / epidemiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Registries*
  • United States / epidemiology

Supplementary concepts

  • Amyloidosis, Hereditary, Transthyretin-Related