Journal of Comparative Effectiveness Research (Jun 2024)

Six-minute walk test as clinical end point in cardiomyopathy clinical trials, including ATTR-CM: a systematic literature review

  • Jose Nativi-Nicolau,
  • Ali Yilmaz,
  • Noel Dasgupta,
  • Richard Macey,
  • James Cochrane,
  • Judith Peatman,
  • Catherine Summers,
  • Jennifer Luth,
  • Ronald Zolty

DOI
https://doi.org/10.57264/cer-2023-0158
Journal volume & issue
Vol. 13, no. 7

Abstract

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Aim: The six-minute walk test (6MWT) is a common measure of functional capacity in patients with heart failure (HF). Primary clinical study end points in cardiomyopathy (CM) trials, including transthyretin-mediated amyloidosis with CM (ATTR-CM), are often limited to hospitalization and mortality. Objective: To investigate the relationship between the 6MWT and hospitalization or mortality in CM, including ATTR-CM. Method: A PRISMA-guided systematic literature review was conducted using search terms for CM, 6MWT, hospitalization and mortality. Results: Forty-one studies were identified that reported 6MWT data and hospitalization or mortality data for patients with CM. The data suggest that a greater 6MWT distance is associated with a reduced risk of hospitalization or mortality in CM. Conclusion: The 6MWT is an accepted alternative end point in CM trials, including ATTR-CM.

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