Heart FailureEdemaTraditional Japanese MedicineKampo MedicineClinical Trial
Investigational drug(s) / intervention(s)
GoreisanStandard Treatment
Goreisan: Add Goreisan 7.5g per day to standard treatment with the intention to reduce or discontinue the existing diuretics
Standard Treatment: Standard therapy without Goreisan
Study 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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Improvement of cardiac edema — 1 year Cardiac edema is defined as conditions having one or more following conditions: lower limb edema, pleural effusion, or pulmonary congestion on chest x-ray. Lower limb edema, pleural effusion, and pulmonary congestion are assessed by investigators. Improvement is defined as the disappearance of all signs of cardiac edema.
Composite endpoint of all-cause death or hospitalization — 3 years Composite of death from any cause or hospitalization from any cause.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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