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

Publication Details

Journal of Comparative Effectiveness Research

June 2024

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Author(s)

Jose Nativi-Nicolau¹, Ali Yilmaz², Noel Dasgupta³, Richard Macey⁴, James Cochrane⁴, Judith Peatman⁴, Catherine Summers⁵, Jennifer Luth⁵, Ronald Zolty⁶

Affiliations

¹Department of Transplant, Mayo Clinic, Jacksonville, FL 32224, USA; ²Division of Cardiovascular Imaging, University Hospital Münster, 48149, Münster, Germany; ³Department of Medicine, Indiana University School of Medicine, Indianapolis, IN 46202, USA; ⁴Adelphi Values PROVETM, Bollington, Cheshire, UK, SK10 5JB; ⁵Medical Affairs Department, Alnylam Pharmaceuticals, Cambridge, MA 02142, USA; ⁶Division of Cardiovascular Medicine, University of Nebraska Medical Center (UNMC), Omaha, NE 68198 USA

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.

Methods:

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.