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

Study Overview

• Status: Completed
• Conditions: Heart Failure,
• Intervention / Treatment: Drug: Levocarnitine placebo; Drug: Levocarnitine Injection

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 Type: Interventional
• Enrollment (Actual): 268
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Shanghai Pulmonary Hospital affiliated to Tongji University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA cardiac functional grading	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.	7 days treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other efficacy evaluations	6-Minute Walk Test (6MWT)	7 days treatment
Other efficacy evaluations	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	7 days treatment
Other efficacy evaluations	Plasma L-carnitine level (acyl-carnitine/free carnitine)	7 days treatment
Other efficacy evaluations	ultrasound echocardiography to measure left ventricular ejection fraction (LVEF)	7 days treatment
Other efficacy evaluations	measure the N-Terminal-pro brain natriuretic peptide level in serum	7 days treatment

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 28, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Estimate): April 27, 2012
• Last Update Submitted That Met QC Criteria: April 26, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: safety; Heart failure; efficacy; L-carnitine; injection
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: LeesPharm_LC-HF