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
  Purpose

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 Intervention Phase
Heart Failure,
Drug: Levocarnitine Injection
Drug: Levocarnitine placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Lee's Pharmaceutical Limited:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


Enrollment: 268
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Levocarnitine Drug: Levocarnitine placebo
L-Carnitine injection placebo (5ml:1g)
Active Comparator: L-carnitine Drug: Levocarnitine Injection
Levocarnitine Injection:5ml:1g

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580553

Locations
China
Shanghai Pulmonary Hospital affiliated to Tongji University
Shanghai, China, 200433
Sponsors and Collaborators
Lee's Pharmaceutical Limited
  More Information

No publications provided

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01580553     History of Changes
Other Study ID Numbers: LeesPharm_LC-HF
Study First Received: March 28, 2012
Last Updated: April 26, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Lee's Pharmaceutical Limited:
Heart failure
L-carnitine
injection
safety
efficacy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014