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

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posted on 2024-06-28, 13:35 authored by Jose Nativi-Nicolau, Ali YilmazAli Yilmaz, Noel Dasgupta, Richard Macey, James Cochrane, Judith Peatman, Catherine Summers, Jennifer Luthman, Ronald Zolty

These are peer-reviewed supplementary materials for the article 'Six-minute walk test as clinical end point in cardiomyopathy clinical trials, including ATTR-CM: a systematic literature review' published in the Journal of Comparative Effectiveness Research.

  • Table S1: Embase search strategy: combining 6MWT, mortality, hospitalization, and HF.
  • Table S2: Medline search strategy: combining 6MWT, mortality, hospitalization, and HF.
  • Table S3: Gray literature – Conferences searched.
  • Table S4: JBI Risk of bias assessment — randomized controlled trials
  • Table S5: JBI Risk of bias assessment — cross sectional
  • Table S6: JBI Risk of bias assessment — cohort
  • Table S7: Study and population characteristics
  • Table S8: 6MWT and hospitalization: separate outcomes
  • Table S9: 6MWT and mortality: separate outcomes

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.

Funding

This study was funded by Alnylam Pharmaceuticals. Adelphi Values PROVE™ received funding from Alnylam Pharmaceuticals for the conduct of the review, from development of the systematic review methodology through to overseeing the final formatting and manuscript submission processes.

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