The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01580553|
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : April 27, 2012
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 or disease||Intervention/treatment||Phase|
|Heart Failure,||Drug: Levocarnitine Injection Drug: Levocarnitine placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||268 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||January 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
|Placebo Comparator: Levocarnitine||
Drug: Levocarnitine placebo
L-Carnitine injection placebo (5ml:1g)
|Active Comparator: L-carnitine||
Drug: Levocarnitine Injection
- NYHA cardiac functional grading [ Time Frame: 7 days treatment ]
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.
- Other efficacy evaluations [ Time Frame: 7 days treatment ]6-Minute Walk Test (6MWT)
- Other efficacy evaluations [ Time Frame: 7 days treatment ]
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
- Other efficacy evaluations [ Time Frame: 7 days treatment ]Plasma L-carnitine level (acyl-carnitine/free carnitine)
- Other efficacy evaluations [ Time Frame: 7 days treatment ]ultrasound echocardiography to measure left ventricular ejection fraction (LVEF)
- Other efficacy evaluations [ Time Frame: 7 days treatment ]measure the N-Terminal-pro brain natriuretic peptide level in serum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580553
|Shanghai Pulmonary Hospital affiliated to Tongji University|
|Shanghai, China, 200433|