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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:
NCT01580553
First received: March 28, 2012
Last updated: April 26, 2012
Last verified: April 2012

March 28, 2012
April 26, 2012
January 2011
March 2012   (final data collection date for primary outcome measure)
NYHA cardiac functional grading [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]

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.

Same as current
Complete list of historical versions of study NCT01580553 on ClinicalTrials.gov Archive Site
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]
    6-Minute Walk Test (6MWT)
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]

    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
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]
    Plasma L-carnitine level (acyl-carnitine/free carnitine)
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]
    ultrasound echocardiography to measure left ventricular ejection fraction (LVEF)
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]
    measure the N-Terminal-pro brain natriuretic peptide level in serum
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]
    6-Minute Walk Test (6MWT)
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]

    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
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]
    Plasma L-carnitine level (acyl-carnitine/free carnitine)
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]
    3.UCG (LVEF)
  • Other efficacy evaluations [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]
    NT-proBNP
Not Provided
Not Provided
 
The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure
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

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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Heart Failure,
  • Drug: Levocarnitine Injection
    Levocarnitine Injection:5ml:1g
  • Drug: Levocarnitine placebo
    L-Carnitine injection placebo (5ml:1g)
  • Placebo Comparator: Levocarnitine
    Intervention: Drug: Levocarnitine placebo
  • Active Comparator: L-carnitine
    Intervention: Drug: Levocarnitine Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01580553
LeesPharm_LC-HF
No
Lee's Pharmaceutical Limited
Lee's Pharmaceutical Limited
Not Provided
Not Provided
Lee's Pharmaceutical Limited
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP