NCT02135835已完成4 期
A Multicentre, Parallel-Group, Randomised, Double-Blind Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure.
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.25 个研究点 分布在 1 个国家目标入组 365 人开始时间: 2014年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 25
- 主要终点
- Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Acute Heart Failure according to Guidelines for the diagnosis and treatment of acute heart failure 2010 of Chinese Medical Association(Participants whose Heart function grade of NYHA is Ⅲ～Ⅳ).
- •LVEF≤40%.
- •NT-pro-BNP ≥1400 pg/mL or BNP ≥ 350pg/mL.
- •Ages 18-80, male or female.
- •All participants signed the informed consent.
排除标准
- •Participants with abnormal liver function (ALT, AST≥3 times of upper limit of normal) or abnormal kidney function( Cr≥1.5 times of upper limit of normal or Cr >3.0 mg/dl (> 265 µmol/L)).
- •SBP ≥ 150mmHg.
- •Participants with severe chronic asthmatic bronchitis or acute episode of lung diseases.
- •Participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery.
- •Participants with advanced cancer.
- •Breastfeeding, pregnant and potentially fertile women participant.
- •Participants with insanity.
- •Known allergies with Shenfu Zhusheye or its ingredients in the past.
- •Participants who have taken part in other clinical trials in last month.
- •Participants who abuse alcohol or other drugs in last year.
- •Participants who are not suitable for clinical trial under doctors' consideration.
研究组 & 干预措施
Shenfu Zhusheye
Experimental
80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days.
干预措施: Shenfu Zhusheye (Drug)
Shenfu Zhusheye
Experimental
80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days.
干预措施: 5% glucose injection (Drug)
5% glucose injection
Placebo Comparator
150 ml 5% glucose injection, ivdrip, once a day for 7 days.
干预措施: 5% glucose injection (Drug)
结局指标
主要结局
Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.
时间窗: 0, 7 days
次要结局
- Likert rating scale of Dyspnoea.(0, 7 days.)
- Decrease rate in NT-proBNP compared to pre-treatment.(0, 7 days.)
- Decrease value in NT-proBNP compared to pre-treatment.(0, 7 days.)
- The results of Transthoracic Doppler-echocardiography .(0, 7 days.)
- Heart function grade of NYHA.(0, 7 days.)
- Composite endpoints.(Composite endpoints will be assessed during medication period and 28 days after medication.)
- Safety assessments will be based on adverse event reports and the results of clinical laboratory tests, electrocardiogram.(Adverse event reports will be assessed during medication period and 28 days after medication. Clinical laboratory tests will be assessed at 0, 7 days.)
研究者
研究点 (25)
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