GOREISAN for Heart Failure (GOREISAN-HF) Trial

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeshi Morimoto

Criteria

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