GOREISAN for Heart Failure (GOREISAN-HF) Trial

NCT04691700 | Active Not Recruiting Phase 4 DMC

• 2 other identifiers: Y0075jRCT
• Study Type: interventional
• Target: 1,179
• Locations: 1 country
• Sites: 1

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 edema and clinical outcomes in worsening congestive heart failure with volume overload.

Conditions

Heart Failure; Edema; Kampo Medicine; Traditional Japanese Medicine; Clinical Trial

Keywords

Heart Failure; Edema; Traditional Japanese Medicine; Goreisan (TJ-17); Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Improvement of cardiac edema

  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.

  1 year

• Composite endpoint of all-cause death or hospitalization

  Composite of death from any cause or hospitalization from any cause.

  3 years

Secondary Outcomes (18)

• Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score

  6 months

• Change in loop diuretics dose

  6 months

• Change in loop diuretics dose

  1 year

• Composite endpoint of sustained decline in eGFR ≥50%, ESRD (end stage renal disease) or renal death

  3 years

• Adverse drug event

  3 years

Study Arms (2)

Goreisan

ACTIVE COMPARATOR

Goreisan (TJ-17) will be added at a dose of 7.5g per day to standard treatment

Drug: Goreisan

No Goreisan

ACTIVE COMPARATOR

Standard treatment without Goreisan (TJ-17)

Drug: Standard Treatment

Interventions

Goreisan DRUG

Add Goreisan 7.5g per day to standard treatment with the intention to reduce or discontinue the existing diuretics

Goreisan

Standard Treatment DRUG

Standard therapy without Goreisan

No Goreisan

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Takeshi Morimoto: lead

Study Sites (1)

Kyoto University Graduate School of Medicine

Kyoto, Kyoto, 606-8507, Japan

Location

Related Publications (1)

• Yaku H, Kato T, Morimoto T, Kaneda K, Nishikawa R, Kitai T, Inuzuka Y, Tamaki Y, Yamazaki T, Kitamura J, Ezaki H, Nagao K, Yamamoto H, Isotani A, Takeshi A, Izumi C, Sato Y, Nakagawa Y, Matoba S, Sakata Y, Kuwahara K, Kimura T; GOREISAN-HF trial Investigators. Rationale and study design of the GOREISAN for heart failure (GOREISAN-HF) trial: A randomized clinical trial. Am Heart J. 2023 Jun;260:18-25. doi: 10.1016/j.ahj.2023.02.013. Epub 2023 Feb 24.

  PMID: 36841318 DERIVED

MeSH Terms

Conditions

Heart Failure; Edema

Interventions

oryeongsan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Takeshi Kimura, MD, PhD

  Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 31, 2020
• Study Start: January 19, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)