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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01580553
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Study Description
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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


Condition or disease Intervention/treatment Phase
Heart Failure, Drug: Levocarnitine Injection Drug: Levocarnitine placebo Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Levocarnitine Drug: Levocarnitine placebo
L-Carnitine injection placebo (5ml:1g)
Active Comparator: L-carnitine Drug: Levocarnitine Injection
Levocarnitine Injection:5ml:1g


Outcome Measures
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Primary Outcome Measures :
  1. NYHA cardiac functional grading [ Time Frame: 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.



Secondary Outcome Measures :
  1. Other efficacy evaluations [ Time Frame: 7 days treatment ]
    6-Minute Walk Test (6MWT)

  2. Other efficacy evaluations [ Time Frame: 7 days treatment ]

    2.Incidence of major cardiovascular events when follow-up (within 1 month)

    • symptoms get worse (NYHA cardiac functional grading aggravates)
    • increase dosage or other treatment for aggravating heart failure
    • need hospitalization again for heart failure or other reasons
    • death

  3. Other efficacy evaluations [ Time Frame: 7 days treatment ]
    Plasma L-carnitine level (acyl-carnitine/free carnitine)

  4. Other efficacy evaluations [ Time Frame: 7 days treatment ]
    ultrasound echocardiography to measure left ventricular ejection fraction (LVEF)

  5. Other efficacy evaluations [ Time Frame: 7 days treatment ]
    measure the N-Terminal-pro brain natriuretic peptide level in serum


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580553


Locations
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China
Shanghai Pulmonary Hospital affiliated to Tongji University
Shanghai, China, 200433
Sponsors and Collaborators
Lee's Pharmaceutical Limited
More Information
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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01580553    
Other Study ID Numbers: LeesPharm_LC-HF
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Lee's Pharmaceutical Limited:
Heart failure
L-carnitine
injection
safety
efficacy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases