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| Descriptive Information Fields | |||||
| Brief Title † | Natrecor in Pulmonary Hypertension | ||||
| Official Title † | Phase IV, Open Labeled Study to Test the Effectiveness of Nesiritide in Reversing Pulmonary Hypertension in Patients Who Will Be Undergoing CardioThoracic Surgery | ||||
| Brief Summary | The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Pulmonary Hypertension Cancer Lung Disease Cardiothoracic Surgery |
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| Intervention † | Drug: Nesiritide (Natrecor) | ||||
| MEDLINE PMIDs | |||||
| Links | Drug information ![]() MD Anderson Cancer Center, Department of Cardiology  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 20 | ||||
| Start Date † | January 2004 | ||||
| Completion Date | May 2005 | ||||
| Eligibility Criteria † | The patient population recruited for this study will include patients being considered for cardiothoracic surgery, as treatment for their cancer, who have evidence of PHTN documented by 2-dimensional and Doppler echocardiography (2D-Echo) uncovered during their pre-operative evaluation for malignancy. Eligible patients include those who have normal LV systolic function with PHTN by Doppler echocardiography, defined as a peak tricuspid velocity of 2.5m/sec or greater without evidence of significant valvular disease. An evaluation for pulmonary hypertension by 2D-Echo will have already been completed by the time the patient is considered for this study. Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00075179 | ||||
| Organization ID | 2003-0562 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | M.D. Anderson Cancer Center | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | March 2006 | ||||
| First Received Date † | January 5, 2004 | ||||
| Last Updated Date | March 28, 2006 | ||||