Goreisan treatment for heart failure
GOREISAN for Heart Failure (GOREISAN-HF) Trial
This study is testing if adding a traditional Japanese medicine called Goreisan to standard heart failure treatment can help people with fluid overload feel better and improve their health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1164 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Kyoto University, Graduate School of Medicine Academic / other |
| Locations | 1 site (Kyoto) |
| Trial ID | NCT04691700 on ClinicalTrials.gov |
What this trial studies
The GOREISAN-HF trial aims to evaluate the effectiveness of Goreisan (TJ-17), a traditional Japanese medicine, in combination with standard therapy for patients experiencing worsening congestive heart failure with volume overload. This multicenter, randomized, open-label trial will compare the outcomes of patients receiving Goreisan alongside standard treatment to those receiving standard treatment alone. The focus is on improving cardiac edema and overall clinical outcomes while minimizing the adverse effects associated with loop diuretics. The trial will include patients with confirmed heart failure and clear signs of fluid overload.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older with confirmed congestive heart failure and signs of cardiac edema.
Not a fit: Patients with recent valvular surgery, cardiac device implantation, or end-stage renal failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer alternative to loop diuretics for managing heart failure symptoms and improving patient outcomes.
How similar studies have performed: While traditional Japanese medicine approaches are less common in Western clinical trials, there is emerging interest in their potential benefits, though this specific combination has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kyoto
- Kyoto University Graduate School of Medicine — Kyoto, Japan (Recruiting)
Study contacts
- Study coordinator: Takeshi Kimura, MD, PhD
- Email: taketaka@kuhp.kyoto-u.ac.jp
- Phone: +81-75-751-4254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.