GOREISAN for Heart Failure (GOREISAN-HF) Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,179
- 试验地点
- 1
- 主要终点
- Composite endpoint of all-cause death or hospitalization
研究概览
简要总结
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.
详细描述
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 activate the renin-angiotensin-aldosterone system and the sympathetic nervous system, which could accelerate HF progression. Loop diuretics could also cause worsening renal function and electrolyte disturbance, and it is desirable to have an alternative drug to loop diuretics to effectively relieve congestive symptoms. Goreisan (TJ-17), a traditional Japanese medicine composed of five herbal medicines, has long been used in Japan to treat impairments of the regulation of body fluid homeostasis, including edema, and has been less likely to cause renal dysfunction and electrolyte abnormalities. We therefore planned a multicenter, randomized, interventional, parallel assignment, open-label treatment trial to evaluate the long-term effect of in-hospital initiation of Goreisan, when added to standard therapy, in patients with worsening congestive heart failure and clear signs of volume overload.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Goreisan
Goreisan (TJ-17) will be added at a dose of 7.5g per day to standard treatment
干预措施: Goreisan (Drug)
No Goreisan
Standard treatment without Goreisan (TJ-17)
干预措施: Standard Treatment (Drug)
结局指标
主要结局
Composite endpoint of all-cause death or hospitalization
时间窗: 3 years
Composite of death from any cause or hospitalization from any cause.
Improvement of cardiac edema
时间窗: 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.
次要结局
- Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score(6 months)
- Composite endpoint of sustained decline in eGFR ≥50%, ESRD (end stage renal disease) or renal death(3 years)
- Adverse drug event(3 years)
- Change in loop diuretics dose(1 year)
- Change in a composite congestion score(1 year)
- All-cause hospitalization(3 years)
- Composite endpoint of all-cause death or hospitalization for heart failure(3 years)
- Hospitalization for heart failure(3 years)
- All-cause death(3 years)
- Non-cardiovascular death(3 years)
- Change in New York Heart Association (NYHA) functional class(6 months)
- Change in N-terminal pro brain-type natriuretic peptide (NT-proBNP)(1 year)
- Direct healthcare cost(1 year)
- Change in loop diuretics dose(6 months)
- Change in a composite congestion score(1 month)
- Change in a composite congestion score(6 months)
- Change in N-terminal pro brain-type natriuretic peptide (NT-proBNP)(1 month)
- Change in N-terminal pro brain-type natriuretic peptide (NT-proBNP)(6 month)
研究者
Takeshi Morimoto
Professor of Medicine
Kyoto University, Graduate School of Medicine