NCT04691700Active, not recruitingPhase 4
GOREISAN for Heart Failure (GOREISAN-HF) Trial
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1179 (actual)
- First submitted
- 20 Dec 2020
- Start date
- 19 Jan 2021
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Takeshi Morimoto
- Diseases
- Heart failure
- NCT number
- NCT04691700
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1179
- From 19 Jan 2021 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Treatment with herbal medicine at enrollment
Other illness
- Acute coronary syndrome at screening
- Confirmed poor tolerability of Goreisan (including cinnamon allergy)
Lab values
- End-stage renal failure (estimated glomerular filtration rate \[eGFR\] \<15 mL/min/1.73m2) at enrollment
Other
- Patients who are expected to have a life expectancy of 6 months or less
- Women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization
- Considered not appropriate for the participation of the study
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyoto University Graduate School of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.