The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure
NCT ID: NCT01580553
Last Updated: 2012-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
268 participants
INTERVENTIONAL
2011-01-31
2012-03-31
Brief Summary
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A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical study was performed.
Treatment period: 7 days, follow-up: 1 month
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Levocarnitine
Levocarnitine placebo
L-Carnitine injection placebo (5ml:1g)
L-carnitine
Levocarnitine Injection
Levocarnitine Injection:5ml:1g
Interventions
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Levocarnitine Injection
Levocarnitine Injection:5ml:1g
Levocarnitine placebo
L-Carnitine injection placebo (5ml:1g)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Lee's Pharmaceutical Limited
INDUSTRY
Responsible Party
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Locations
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Shanghai Pulmonary Hospital affiliated to Tongji University
Shanghai, , China
Countries
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Other Identifiers
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LeesPharm_LC-HF
Identifier Type: -
Identifier Source: org_study_id
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