Effects of "ShengXian-QuYu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced and Mildly Reduced Ejection Fraction: a Pragmatic, Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 336
- 试验地点
- 26
- 主要终点
- Change From Baseline in the KCCQ Clinical Summary Score
研究概览
简要总结
The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "ShengXian-QuYu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.
详细描述
This is a pragmatic, nationwide, multicenter, parallel group, randomized, double-blind, placebo-controlled study in patients with heart failure with reduced and mildly ejection fraction, evaluating the effect of "ShengXian-QuYu Decoction" versus placebo, given twice daily in addition to background regional standard of care. The effect of "ShengXian-QuYu Decoction"on quality of life, symptoms and biomarkers will be evaluated.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, Traditional Chinese Medicine syndrome type, diabetes status, kidney function, left ventricular ejection fraction, natriuretic peptide, and additional co-morbidities, concomitant medications, and others.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥18 years at the time of consent.
- •Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).
- •LVEF <50%.
- •NT-proBNP >600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment.
- •Provision of signed informed consent prior to any study specific procedures.
排除标准
- •Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment.
- •Uncontrolled severe arrhythmia.
- •Planned to undergo heart transplantation or device implantation.
- •Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment).
- •Severe infection.
- •eGFR <30 mL/min/1.73 m^2 by CKD-EPI.
- •Active malignancy requiring treatment at the time of visit
- •Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
- •Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement.
- •Systolic blood pressure < 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements.
- •Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis.
- •Participation in another clinical study.
- •Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
研究组 & 干预措施
ShengXian-QuYu Decoction
Patients will be randomized 1:1 to either ShengXian-QuYu Decoction or placebo. "ShengXian-QuYu Decoction" (calculated by a medicine): 30g of Astragalus membranaceus (Huangqi), 12g of Cornus officinalis (Shanzhuyu), 9g of Panax ginseng (Hongshen), 12g of Anemarrhena asphodeloides (Zhimu), 8g of Cimicifuga foetida (Shengma), 8g of Bupleurum chinense (Chaihu), 10g of Platycodon grandiflorum (Jiegeng), 10g of Sparganium stoloniferum (Sanleng), 9g of Curcuma phaeocaulis (Ezhu), 3g of Whitmania pigra (Shuizhi).
干预措施: ShengXian-QuYu Decoction (Drug)
placebo
Placebo matching ShengXian-QuYu Decoction
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in the KCCQ Clinical Summary Score
时间窗: Up to 12 weeks
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
次要结局
- Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)(Up to 26 weeks)
- Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance(Up to 12 weeks)
- Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)(Up to 12 weeks)
- Change in Left Ventricular Systolic Function(Up to 12 weeks)
- Change in Left Ventricular End-Diastolic Diameter(Up to 12 weeks)
- Change in Left Ventricular End-Systolic Diameter(Up to 12 weeks)
- Change in Estimated Glomerular Filtration Rate from Baseline(Up to 12 weeks)
- Change From Baseline in the KCCQ Clinical Summary Score(Up to 26 weeks)
研究者
Jingyi Ren
Professor
China-Japan Friendship Hospital