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

NCT01580553 | Completed Phase 2

• 1 other identifier: LeesPharm_LC-HF
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure,

Keywords

Heart failure; L-carnitine; injection; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Other efficacy evaluations

  7 days treatment

• Other efficacy evaluations

  7 days treatment

• Other efficacy evaluations

  7 days treatment

• Other efficacy evaluations

  7 days treatment

• Other efficacy evaluations

  7 days treatment

Study Arms (2)

Levocarnitine

PLACEBO COMPARATOR

Drug: Levocarnitine placebo

L-carnitine

ACTIVE COMPARATOR

Drug: Levocarnitine Injection

Interventions

Levocarnitine Injection DRUG

Levocarnitine Injection:5ml:1g

L-carnitine

Levocarnitine placebo DRUG

L-Carnitine injection placebo (5ml:1g)

Levocarnitine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject aged ≥ 18 years, men or women.
• 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).
• The subject needs hospitalization because of heart failure and will stay in hospital for more than 7 days.
• NYHA-FC is Class II- IV (Class II cases \< 20%, except the refractory terminal heart failure patients).
• The subject's UCG shows that LVEF ≤ 45％ (left heart failure).
• CI \< 2.5 L/min/m2 or CO \< 4L/min (right heart failure)
• The subject has signed the ICF.

You may not qualify if:

• Subjects with medical history of heart failure caused by valvular heart disease, mechanical obstruction, pericardial disease and myocardial amyloidosis.
• Subjects with heart function Class IV that have unstable hemodynamics and need final stage cardiac transplantation and intravenous vasoactive drugs.
• Subjects will leave the hospital in 7 days.
• Subjects with severe cerebral apoplexy (life threatening).
• Subjects with AMI or acute pulmonary embolism.
• Subjects with uremia and did not undergo dialysis.
• Subjects with COPD.
• Subjects with severe anemia (Hb≤60g/l).
• Subject who is receiving other metabolism improving drugs within one month (such as trimetazidine dihydrochloride tablets and 1, 6- fructose diphosphate.
• Subject with other severe disease and his/her life expectancy \<12 months.
• Subject who has participated in other clinical trial within 3 months or is participating in other study.
• Subject who has received L-carnitine treatment within 1 month.
• Subject who is allergic to L-carnitine and its derivatives.
• Subject is receiving other cardiotoxic drugs.
• Subjects with medical history of epilepsy.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Shanghai Pulmonary Hospital affiliated to Tongji University

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 19, 2012
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

CN (1)