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Terminated for administrative reasons not related to safety or efficacy
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The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical marker and functional benefit to damaged heart muscle cells. This will be evaluated by measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vepoloxamer - Low dose | Experimental | Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours |
|
| Vepoloxamer - High dose | Experimental | Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours |
|
| 5% dextrose in water (D5W) | Placebo Comparator | D5W administered intravenously over 3 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vepoloxamer | Drug |
| ||
| 5% dextrose in water |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP | Study Day 1 through Study Day 30 | |
| Number of subjects with a change in Six Minute Walk test | Study Day 1 to Study Day 30 | |
| Number of subjects with a change in Borg dyspnea index | Study Day 1 to Study Day 30 | |
| Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire® | Study Day 1 to Study Day 30 | |
| Number of subjects with a change in left ventricular end diastolic volume index | Study Day 1 to Study Day 30 | |
| Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03 | Study Day 1 to Study Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edwin L. Parsley, D.O. | Mast Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Detroit | Michigan | 48202 | United States | ||
| Research Center |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 |
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| Other |
|
|
| Tupelo |
| Mississippi |
| 38801 |
| United States |
| Research Center | Cardiff | New South Wales | 2285 | Australia |
| Research Center | Melbourne | Victoria | Australia |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |