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

Last updated: April 26, 2012
Sponsor: Lee's Pharmaceutical Limited
Overall Status: Completed

Phase

2/3

Condition

Heart Failure

Congestive Heart Failure

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT01580553
LeesPharm_LC-HF
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 pastmedical history of left heart failure caused by coronary heart disease, hypertensionand dilated cardiomyopathy, or a medical history of right heart failure caused bypulmonary artery hypertension (the 1st type of diagnostic classification, WHOconference, Venice, 2003) and left heart disease (the 2nd type) ;the case number ofright heart failure is about 30% of the total case number).

  3. The subject needs hospitalization because of heart failure and will stay in hospitalfor more than 7 days.

  4. NYHA-FC is Class II- IV (Class II cases < 20%, except the refractory terminal heartfailure 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

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 finalstage 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 astrimetazidine 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 isparticipating 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 nottaken contraception measures.

  20. The subject has not signed the ICF.

Study Design

Total Participants: 268
Study Start date:
January 01, 2011
Estimated Completion Date:
March 31, 2012

Study 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.

Connect with a study center

  • Shanghai Pulmonary Hospital affiliated to Tongji University

    Shanghai, 200433
    China

    Site Not Available

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