Heart failure & cardiomyopathies

Rationale and design of the Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure Trial (ARISE-HF) in patients with high-risk diabetic cardiomyopathy

Am Heart JPublished Rationale and design of a randomised controlled trial

Study context

Population
T2DM patients with diabetic cardiomyopathy at high risk of progression to overt heart failure (HF)fully enrolled
Participants
675 patients
Planned comparison
AT-001 vs placebo
Primary endpoint
Exercise capacity: change in peak VO2
Follow-up
15 (and possibly 27) months
Methodological detailsPhase 3, placebo-controlled, double-blind, global, Additional endpoints: progression to overt HF, health status, echocardiographic measures, cardiac biomarkers
  • Phase 3
  • Placebo-controlled
  • Double-blind
  • Global
  • Additional endpoints: progression to overt HF, health status, echocardiographic measures, cardiac biomarkers

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Rationale and design of the Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure Trial (ARISE-HF) in patients with high-risk diabetic cardiomyopathy. Am Heart J. Published 11 November 2022. doi:10.1016/j.ahj.2022.11.003

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