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| ID | Type | Description | Link |
|---|---|---|---|
| MK7418-503 | |||
| 2008_532 |
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| Name | Class |
|---|---|
| NovaCardia, Inc. | UNKNOWN |
The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | rolofylline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Placebo | Drug | rolofylline placebo IV infusion over 4 hours. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change in pulmonary capillary wedge pressure | from baseline to 4 and 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure | from baseline to 4 and 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20823097 | Result | Ponikowski P, Mitrovic V, O'Connor CM, Dittrich H, Cotter G, Massie BM, Givertz MM, Chen E, Murray M, Weatherley BD, Fujita KP, Metra M. Haemodynamic effects of rolofylline in the treatment of patients with heart failure and impaired renal function. Eur J Heart Fail. 2010 Nov;12(11):1238-46. doi: 10.1093/eurjhf/hfq137. Epub 2010 Sep 7. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C073525 | rolofylline |
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| rolofylline |
| Drug |
rolofylline 30 mg IV infusion over 4 hours. |
|