Heart failure & cardiomyopathies

Rationale and study design of the GOREISAN for heart failure (GOREISAN-HF) trial: A randomized clinical trial

Am Heart JPublished Randomised controlled trial

Study context

Population
Patients hospitalized for heart failure (HF) with volume overload, Japanplanned enrolment
Participants
2,192 patients
Planned comparison
Goreisan added to usual care vs usual care alone
Primary endpoint
Improvement rate of cardiac edema; co-primary: composite of all-cause death or hospitalization up to end of planned follow-up
Follow-up
12-month follow-up
Methodological detailsstudy design and rationale, investigator-initiated, multicenter, pragmatic, comparative effectiveness, 68 hospitals in Japan, Investigators may change the existing diuretic regimen in both groups
  • Study design and rationale
  • Investigator-initiated
  • Multicenter
  • Pragmatic
  • Comparative effectiveness
  • 68 hospitals in Japan
  • Investigators may change the existing diuretic regimen in both groups

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

Original publication

Rationale and study design of the GOREISAN for heart failure (GOREISAN-HF) trial: A randomized clinical trial. Am Heart J. Published 24 February 2023. doi:10.1016/j.ahj.2023.02.013

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