Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | January 5, 2004 | ||||
Last Updated Date | March 28, 2006 | ||||
Start Date † | January 2004 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00075179 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
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. |
||||
Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
Condition † |
|
||||
Intervention † | Drug: Nesiritide (Natrecor) | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Terminated | ||||
Enrollment † | 20 | ||||
Completion Date | May 2005 | ||||
Primary Completion Date | |||||
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:
|
||||
Gender | Both | ||||
Ages | 18 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00075179 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | M.D. Anderson Cancer Center | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | March 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |