GOREISAN for Heart Failure (GOREISAN-HF) Trial

Takeshi Morimoto

Status and phase: Active, not recruiting; Phase 4

Conditions: Edema; Kampo Medicine; Clinical Trial; Heart Failure; Traditional Japanese Medicine

Treatments: Drug: Goreisan; Drug: Standard Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04691700

Y0075

jRCT (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,179 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed congestive heart failure (CHF) by Framingham criteria
• CHF patients with cardiac edema and signs due to cardiac edema (signs of fluid overload: lower limb edema, pulmonary effusion, or pulmonary congestion on chest x-ray)
• Elevated N-terminal pro brain-type natriuretic peptide (NT-proBNP) ≥300 pg/mL or brain natriuretic peptide (BNP) ≥100 pg/mL at enrollment
• Patients ≥ 20 years of age, male or female
• Provision of signed informed consent before any assessment is performed

Exclusion criteria

• Valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
• Implantation of a cardiac resynchronization therapy (CRT) within 12 weeks prior to enrollment or intent to implant a CRT device
• Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
• End-stage renal failure (estimated glomerular filtration rate [eGFR] <15 mL/min/1.73m2) at enrollment
• Patients who are expected to have a life expectancy of 6 months or less
• Acute coronary syndrome at screening
• Women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization
• Treatment with herbal medicine at enrollment
• Confirmed poor tolerability of Goreisan (including cinnamon allergy)
• Considered not appropriate for the participation of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,179 participants in 2 patient groups

Goreisan

Active Comparator group

Description:

Goreisan (TJ-17) will be added at a dose of 7.5g per day to standard treatment

Treatment:

Drug: Goreisan

No Goreisan

Active Comparator group

Description:

Standard treatment without Goreisan (TJ-17)

Treatment:

Drug: Standard Treatment