Clinical trial NCT01580553: The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure,
Keywords: Heart failure
L-carnitine
injection
safety
efficacy
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2012-04-19
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. The subject aged ≥ 18 years, men or women.
2. 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).
3. The subject needs hospitalization because of heart failure and will stay in hospital for more than 7 days.
4. NYHA-FC is Class II- IV (Class II cases \< 20%, except the refractory terminal heart failure patients).
5. The subject's UCG shows that LVEF ≤ 45％ (left heart failure).
6. CI \< 2.5 L/min/m2 or CO \< 4L/min (right heart failure)
7. The subject has signed the ICF.

Exclusion Criteria:

1. Subjects with medical history of heart failure caused by valvular heart disease, mechanical obstruction, pericardial disease and myocardial amyloidosis.
2. Subjects with heart function Class IV that have unstable hemodynamics and need final stage cardiac transplantation and intravenous vasoactive drugs.
3. Subjects will leave the hospital in 7 days.
4. Subjects with severe cerebral apoplexy (life threatening).
5. Subjects with AMI or acute pulmonary embolism.
6. Subjects with uremia and did not undergo dialysis.
7. Subjects with COPD.
8. Subjects with severe anemia (Hb≤60g/l).
9. Subject who is receiving other metabolism improving drugs within one month (such as trimetazidine dihydrochloride tablets and 1, 6- fructose diphosphate.
10. Subject with other severe disease and his/her life expectancy \<12 months.
11. Subject who has participated in other clinical trial within 3 months or is participating in other study.
12. Subject who has received L-carnitine treatment within 1 month.
13. Subject who is allergic to L-carnitine and its derivatives.
14. Subject is receiving other cardiotoxic drugs.
15. Subjects with medical history of epilepsy.
16. Subject who is a drug or alcohol abuser.
17. Subject who has received PCI, CABG or vascular remodeling.
18. Subject with arrhythmia that the investigator thinks unsuitable to include.
19. The subject who is pregnant or lactating, and the woman of childbearing age has not taken contraception measures.
20. The subject has not signed the ICF.

Primary outcomes:
measure: NYHA cardiac functional grading
timeFrame: 7 days treatment
Secondary outcomes:
measure: Other efficacy evaluations
timeFrame: 7 days treatment
measure: Other efficacy evaluations
timeFrame: 7 days treatment
measure: Other efficacy evaluations
timeFrame: 7 days treatment
measure: Other efficacy evaluations
timeFrame: 7 days treatment
measure: Other efficacy evaluations
timeFrame: 7 days treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital affiliated to Tongji University
Study officials:
References: