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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levocarnitine | Placebo Comparator |
| |
| L-carnitine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levocarnitine Injection | Drug | Levocarnitine Injection:5ml:1g |
| |
| 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 |
| 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)
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital affiliated to Tongji University | Shanghai | 200433 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Levocarnitine placebo |
| Drug |
L-Carnitine injection placebo (5ml:1g) |
|
| 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 |