GOREISAN for Heart Failure (GOREISAN-HF) Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 22 February 2021
• Main ID: NCT04691700
• Date of registration: 20/12/2020
• Prospective Registration: Yes
• Primary sponsor: Takeshi Morimoto
• Public title: GOREISAN for Heart Failure (GOREISAN-HF) Trial GOREISAN-HF
• Scientific title: GOREISAN for Heart Failure (GOREISAN-HF) Trial
• Date of first enrolment: January 19, 2021
• Target sample size: 2192
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04691700
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Japan

Contacts

• Name: Takeshi Kimura, MD, PhD

• Name: Takeshi Kimura, MD, PhD

• Name: Takeshi Kimura, MD, PhD
• Affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Key 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Clinical Trial

Edema

Heart Failure

Kampo Medicine

Traditional Japanese Medicine

Intervention(s)

Drug: Goreisan

Drug: Standard Treatment

Primary Outcome(s)

Composite endpoint of all-cause death or hospitalization [Time Frame: 3 years]

Improvement of cardiac edema [Time Frame: 1 year]

Secondary Outcome(s)

Adverse drug event [Time Frame: 3 years]

All-cause death [Time Frame: 3 years]

All-cause hospitalization [Time Frame: 3 years]

Change in a composite congestion score [Time Frame: 1 month]

Change in a composite congestion score [Time Frame: 1 year]

Change in a composite congestion score [Time Frame: 6 months]

Change in loop diuretics dose [Time Frame: 1 year]

Change in loop diuretics dose [Time Frame: 6 months]

Change in N-terminal pro brain-type natriuretic peptide (NT-proBNP) [Time Frame: 1 month]

Change in N-terminal pro brain-type natriuretic peptide (NT-proBNP) [Time Frame: 1 year]

Change in N-terminal pro brain-type natriuretic peptide (NT-proBNP) [Time Frame: 6 month]

Change in New York Heart Association (NYHA) functional class [Time Frame: 6 months]

Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score [Time Frame: 6 months]

Composite endpoint of all-cause death or hospitalization for heart failure [Time Frame: 3 years]

Composite endpoint of sustained decline in eGFR =50%, ESRD (end stage renal disease) or renal death [Time Frame: 3 years]

Direct healthcare cost [Time Frame: 1 year]

Hospitalization for heart failure [Time Frame: 3 years]

Non-cardiovascular death [Time Frame: 3 years]

Secondary ID(s)

jRCT

Y0075

Source(s) of Monetary Support

Please refer to primary and secondary sponsors