GOREISAN for Heart Failure (GOREISAN-HF) Trial

Y0075

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.

2021-01-19

2024-01-01

2026-03-01

Recruiting

Early phase I

2192

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2192, 'type': 'ESTIMATED'}}

2023-04-03