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Sponsored by: |
M.D. Anderson Cancer Center |
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00075179 |
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.
Condition | Intervention | Phase |
Pulmonary Hypertension Cancer Lung Disease Cardiothoracic Surgery |
Drug: Nesiritide (Natrecor) |
Phase IV |
Genetics Home Reference related topics: | pulmonary arterial hypertension |
MedlinePlus related topics: | Cancer High Blood Pressure Pulmonary Hypertension |
ChemIDplus related topics: | Nesiritide |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
United States, Texas | |||||
MD Anderson Cancer Center | |||||
Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center |
Study Chair: | Daniel J. Lenihan, MD | M.D. Anderson Cancer Center |
Drug information 
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MD Anderson Cancer Center, Department of Cardiology 
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Study ID Numbers: | 2003-0562 |
First Received: | January 5, 2004 |
Last Updated: | March 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00075179 |
Health Authority: | United States: Food and Drug Administration |
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