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| Name | Class |
|---|---|
| Scios, Inc. | INDUSTRY |
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The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nesiritide + standard of care | Experimental | Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved. |
|
| Standard of care | Active Comparator | Standard of care until adequate diuresis achieved |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nesiritide | Drug | Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function | within 7 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Within 7 days from randomization | |
| Days to optimal volume status | From randomization till day 7 or sooner | |
| Concomitant diuretic use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anju Nohria, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D020097 | Natriuretic Peptide, Brain |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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|
| Within 7 days from randomization |
| Global symptom assessment | 24 hrs and 3 days after randomization |
| Length of stay | From admission to discharge or day 7 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |