Status:
ACTIVE_NOT_RECRUITING
GOREISAN for Heart Failure (GOREISAN-HF) Trial
Lead Sponsor:
Takeshi Morimoto
Conditions:
Heart Failure
Edema
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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 ede...
Detailed Description
Current guidelines recommend the use of loop diuretics as an indication for class I to improve HF symptoms regardless of left ventricular ejection fraction. Loop diuretics, however, are known to activ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
1179 Patients enrolled
Trial Details
Trial ID
NCT04691700
Start Date
January 19 2021
End Date
December 31 2027
Last Update
January 6 2026
Active Locations (1)
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1
Kyoto University Graduate School of Medicine
Kyoto, Kyoto, Japan, 606-8507