Back to resultsThe Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure
Primary Purpose
Heart Failure,
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Levocarnitine Injection
Levocarnitine placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, focused on measuring Heart failure, L-carnitine, injection, safety, efficacy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Subject who is a drug or alcohol abuser.
- Subject who has received PCI, CABG or vascular remodeling.
- Subject with arrhythmia that the investigator thinks unsuitable to include.
- The subject who is pregnant or lactating, and the woman of childbearing age has not taken contraception measures.
- The subject has not signed the ICF.
Sites / Locations
- Shanghai Pulmonary Hospital affiliated to Tongji University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Levocarnitine
L-carnitine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Other efficacy evaluations
6-Minute Walk Test (6MWT)
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
Other efficacy evaluations
Plasma L-carnitine level (acyl-carnitine/free carnitine)
Other efficacy evaluations
ultrasound echocardiography to measure left ventricular ejection fraction (LVEF)
Other efficacy evaluations
measure the N-Terminal-pro brain natriuretic peptide level in serum
Full Information
NCT ID
NCT01580553
First Posted
March 28, 2012
Last Updated
April 26, 2012
Sponsor
Lee's Pharmaceutical Limited
1. Study Identification
Unique Protocol Identification Number
NCT01580553
Brief Title
The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure,
Keywords
Heart failure, L-carnitine, injection, safety, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levocarnitine
Arm Type
Placebo Comparator
Arm Title
L-carnitine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Levocarnitine Injection
Intervention Description
Levocarnitine Injection:5ml:1g
Intervention Type
Drug
Intervention Name(s)
Levocarnitine placebo
Intervention Description
L-Carnitine injection placebo (5ml:1g)
Primary Outcome Measure Information:
Title
NYHA cardiac functional grading
Description
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.
Time Frame
7 days treatment
Secondary Outcome Measure Information:
Title
Other efficacy evaluations
Description
6-Minute Walk Test (6MWT)
Time Frame
7 days treatment
Title
Other efficacy evaluations
Description
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
Time Frame
7 days treatment
Title
Other efficacy evaluations
Description
Plasma L-carnitine level (acyl-carnitine/free carnitine)
Time Frame
7 days treatment
Title
Other efficacy evaluations
Description
ultrasound echocardiography to measure left ventricular ejection fraction (LVEF)
Time Frame
7 days treatment
Title
Other efficacy evaluations
Description
measure the N-Terminal-pro brain natriuretic peptide level in serum
Time Frame
7 days treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Subject who is a drug or alcohol abuser.
Subject who has received PCI, CABG or vascular remodeling.
Subject with arrhythmia that the investigator thinks unsuitable to include.
The subject who is pregnant or lactating, and the woman of childbearing age has not taken contraception measures.
The subject has not signed the ICF.
Facility Information:
Facility Name
Shanghai Pulmonary Hospital affiliated to Tongji University
City
Shanghai
ZIP/Postal Code
200433
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure
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