The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.