GOREISAN-HF Trial

JRCT ID: jRCTs051200101

Registered date:22/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute congestive heart failure
• Date of first enrollment: 19/01/2021
• Target sample size: 2192
• Study type: Interventional
• Intervention(s): Goreisan treatment group adding Goreisan with the intention to reduce or discontinue the existing diuretics (Goreisan group) and standard treatment group (No Goreisan group)

Outcome(s)

• Primary Outcome: Improvement of cardiac edema

Secondary Outcome

Change in loop diuretic dose, A composite renal endpoint event (decline in eGFR, doubling of the serum creatinine level from baseline, dialysis, kidney transplantation, or renal death), Change in eGFR, Adverse drug events, A composite congestion score, A composite of all-cause death or rehospitalization for HF, Rehospitalization for HF, All-cause death, Non-cardiovascular death, All-cause rehospitalization, Hospitalization for worsening renal function, Health-related Quality of Life as assessed by the KCCQ-12, EQ-5D-5L, and OTE, Patient-assessed symptoms and physical examinations, NYHA functional class, Biomarkers, Arrhythmia, Stroke, Echocardiography parameters
, Number of urgent outpatient visits and hospitalizations from the time of randomization at 12 months, Direct healthcare cost from the time of randomization at 12 months in a subset of patients

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Confirmed congestive heart failure (CHF) by Framingham criteria
2. CHF patients with symptoms and signs of fluid overload (i.e., lower limb edema, pulmonary effusion, or pulmonary congestion on chest x-ray)
3. Elevated NT-proBNP>=300 pg/mL OR BNP>=100 pg/mL at enrollment
4. Patients>=20 years of age, male or female
5. Provision of signed informed consent before any assessment is performed

Exclude criteria

1. Valvular repair/replacement within 12 weeks prior to enrollment or planned to undergo any of these operations after randomization
2. Implantation of a cardiac CRT within 12 weeks prior to enrollment or intent to implant a CRT device
3. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
4. End-stage renal failure (eGFR <15 mL/min/1.73m2) at enrollment
5. Patients who are expected to have a life prognosis of 6 months or less
6. Acute coronary syndrome at screening
7. Women of child-bearing potential OR women who have a positive pregnancy test at enrolment or randomization
8. Patients who are being treated with Kampo (herbal medicine) at enrollment
9. Confirmed poor tolerability of Goreisan (including cinnamon allergy)
10. Patients who are not appropriate for the participation of the study

Related Information

• Primary Sponsor: Ono Koh
• Secondary Sponsor: Kimura Takeshi,Yaku Hidenori
• Source(s) of Monetary Support: Tsumura &amp; Co.
• Secondary ID(s): NCT04691700