The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure
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
|Heart Failure,||Drug: Levocarnitine Injection Drug: Levocarnitine placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|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|
- 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
|Study Start Date:||January 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Levocarnitine||
Drug: Levocarnitine placebo
L-Carnitine injection placebo (5ml:1g)
|Active Comparator: L-carnitine||
Drug: Levocarnitine Injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580553
|Shanghai Pulmonary Hospital affiliated to Tongji University|
|Shanghai, China, 200433|