The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure -A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- NYHA cardiac functional grading
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of L-carnitine injection in treatment of Chinese patients with heart failure.
A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical study was performed.
Treatment period: 7 days, follow-up: 1 month
详细描述
The primary objective of this study is to assess the efficacy and safety of L-carnitine injection in treatment of Chinese patients with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •The subject aged ≥ 18 years, men or women.
- •The subject has a diagnosis of chronic left heart or right heart failure (a past medical history of left heart failure caused by coronary heart disease, hypertension and dilated cardiomyopathy, or a medical history of right heart failure caused by pulmonary artery hypertension (the 1st type of diagnostic classification, WHO conference, Venice, 2003) and left heart disease (the 2nd type) ;the case number of right heart failure is about 30% of the total case number).
- •The subject needs hospitalization because of heart failure and will stay in hospital for more than 7 days.
- •NYHA-FC is Class II- IV (Class II cases < 20%, except the refractory terminal heart failure patients).
- •The subject's UCG shows that LVEF ≤ 45％ (left heart failure).
- •CI < 2.5 L/min/m2 or CO < 4L/min (right heart failure)
- •The subject has signed the ICF.
排除标准
- •Subjects with medical history of heart failure caused by valvular heart disease, mechanical obstruction, pericardial disease and myocardial amyloidosis.
- •Subjects with heart function Class IV that have unstable hemodynamics and need final stage cardiac transplantation and intravenous vasoactive drugs.
- •Subjects will leave the hospital in 7 days.
- •Subjects with severe cerebral apoplexy (life threatening).
- •Subjects with AMI or acute pulmonary embolism.
- •Subjects with uremia and did not undergo dialysis.
- •Subjects with COPD.
- •Subjects with severe anemia (Hb≤60g/l).
- •Subject who is receiving other metabolism improving drugs within one month (such as trimetazidine dihydrochloride tablets and 1, 6- fructose diphosphate.
- •Subject with other severe disease and his/her life expectancy <12 months.
- •Subject who has participated in other clinical trial within 3 months or is participating in other study.
- •Subject who has received L-carnitine treatment within 1 month.
- •Subject who is allergic to L-carnitine and its derivatives.
- •Subject is receiving other cardiotoxic drugs.
- •Subjects with medical history of epilepsy.
- •Subject who is a drug or alcohol abuser.
- •Subject who has received PCI, CABG or vascular remodeling.
- •Subject with arrhythmia that the investigator thinks unsuitable to include.
- •The subject who is pregnant or lactating, and the woman of childbearing age has not taken contraception measures.
- •The subject has not signed the ICF.
研究组 & 干预措施
Levocarnitine
干预措施: Levocarnitine placebo (Drug)
L-carnitine
干预措施: Levocarnitine Injection (Drug)
结局指标
主要结局
NYHA cardiac functional grading
时间窗: 7 days treatment
The cardiac functional changes between the end of medication (within 24 hrs) and baseline (prior to medication) are evaluated by the three-grade criteria (excellent, effective and no response). And calculate the effective rate. Excellent: cardiac function improved for 2 grades and above Effective: cardiac function improved for one grade No response: failed to achieve the effective criteria.
次要结局
- Other efficacy evaluations(7 days treatment)