NCT04691700

GOREISAN for Heart Failure (GOREISAN-HF) Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,179 (actual)
• Sponsor: Takeshi Morimoto · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objective of the GOREISAN-HF trial is to assess the effect of the administration of Goreisan (TJ-17) plus standard therapy compared to standard therapy alone on the improvement rate of cardiac edema and clinical outcomes in worsening congestive heart failure with volume overload.

Detailed description

Current guidelines recommend the use of loop diuretics as an indication for class I to improve HF symptoms regardless of left ventricular ejection fraction. Loop diuretics, however, are known to activate the renin-angiotensin-aldosterone system and the sympathetic nervous system, which could accelerate HF progression. Loop diuretics could also cause worsening renal function and electrolyte disturbance, and it is desirable to have an alternative drug to loop diuretics to effectively relieve congestive symptoms. Goreisan (TJ-17), a traditional Japanese medicine composed of five herbal medicines, has long been used in Japan to treat impairments of the regulation of body fluid homeostasis, including edema, and has been less likely to cause renal dysfunction and electrolyte abnormalities. We therefore planned a multicenter, randomized, interventional, parallel assignment, open-label treatment trial to evaluate the long-term effect of in-hospital initiation of Goreisan, when added to standard therapy, in patients with worsening congestive heart failure and clear signs of volume overload.

Conditions

• Heart Failure
• Edema
• Traditional Japanese Medicine
• Kampo Medicine
• Clinical Trial

Interventions

Type	Name	Description
DRUG	Goreisan	Add Goreisan 7.5g per day to standard treatment with the intention to reduce or discontinue the existing diuretics
DRUG	Standard Treatment	Standard therapy without Goreisan

Timeline

• Start date: 2021-01-19
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-12-31
• Last updated: 2026-01-06

Locations

1 site across 1 country: Japan