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| Name | Class |
|---|---|
| American College of Clinical Pharmacy | OTHER |
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The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered.
No additional details provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nesiritide Infusion | Experimental | Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. |
|
| Nitroglycerin Infusion | Active Comparator | Nitroglycerin was initiated at 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nesiritide | Drug | Bolus 2 mcg/kg followed by 0.01 mcg/kg/min |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Function by Serum Creatinine | Serum creatinine values and changes in serum creatinine | Baseline, 24 hours, 48 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Markers | Interleukin-6 | 48 hours |
| Serum Levels of Cystatin-C | Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheryl L. Chow, PharmD, FCCP, BCPS | Western University of Heatlh Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centinela Hospital Medical Center | Inglewood | California | 90301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21362524 | Result | Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Renal function and neurohormonal changes following intravenous infusions of nitroglycerin versus nesiritide in patients with acute decompensated heart failure. J Card Fail. 2011 Mar;17(3):181-7. doi: 10.1016/j.cardfail.2010.10.005. Epub 2010 Dec 3. | |
| 21576282 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nesiritide Infusion | 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. |
| FG001 | Nitroglycerin Infusion | 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\ |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nesiritide Infusion | 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. |
| BG001 | Nitroglycerin Infusion | 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Renal Function by Serum Creatinine | Serum creatinine values and changes in serum creatinine | Posted | Apr 2011 | Mean | Standard Deviation | mg/dL | Baseline, 24 hours, 48 hours |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nesiritide Infusion | 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptomatic Hypotension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sheryl L. Chow | Western University of Health Sciences | 9094695379 | schow@westernu.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020097 | Natriuretic Peptide, Brain |
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Nitroglycerin |
| Drug |
5-10 mcg/min titrating per protocol based on blood pressure |
|
| Baseline, 24 hours, 48 hours |
| Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Modulation of novel cardiorenal and inflammatory biomarkers by intravenous nitroglycerin and nesiritide in acute decompensated heart failure: an exploratory study. Circ Heart Fail. 2011 Jul;4(4):450-5. doi: 10.1161/CIRCHEARTFAILURE.110.958066. Epub 2011 May 16. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Sample size was estimated at 90 patients total; however, 1 patient was enrolled twice. Therefore, only 89 patients were enrolled in the primary study. | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Other Pre-specified | Inflammatory Markers | Interleukin-6 | Only participants with available data were assessed for this outcome measure. | Posted | Mean | Standard Error | pg/mL | 48 hours |
|
|
|
| Other Pre-specified | Serum Levels of Cystatin-C | Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function. | Only participants with available data were assessed for this outcome measure. | Posted | Jul 2011 | Mean | Standard Deviation | ng/mL | Baseline, 24 hours, 48 hours |
|
|
|
| 12 |
| 45 |
| 0 |
| 45 |
| EG001 | Nitroglycerin Infusion | 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\ | 12 | 44 | 0 | 44 |
| Death | General disorders | Systematic Assessment | Assessed at 6 months |
|
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| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| Cystatin-C at 48 Hours |
|