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