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. 2024 Jul;13(7):e230158.
doi: 10.57264/cer-2023-0158. Epub 2024 Jun 13.

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

Jose Nativi-Nicolau  1 , Ali Yilmaz  2 , Noel Dasgupta  3 , Richard Macey  4 , James Cochrane  4 , Judith Peatman  4 , Catherine Summers  5 , Jennifer Luth  5 , Ronald Zolty  6
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Six-minute walk test as clinical end point in cardiomyopathy clinical trials, including ATTR-CM: a systematic literature review

Jose Nativi-Nicolau et al. J Comp Eff Res. 2024 Jul.

Abstract

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.

Keywords: 6MWT; ATTR; cardiomyopathy; hospitalization; mortality; six-minute walk test; transthyretin-mediated amyloidosis.

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Figure 1.. PRISMA diagram.
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