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Natrecor in Pulmonary Hypertension

This study has been terminated.
Information provided by M.D. Anderson Cancer Center

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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.

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
Intervention  Drug: Nesiritide (Natrecor)
MEDLINE PMIDs
Links Drug information This link exits the ClinicalTrials.gov site
MD Anderson Cancer Center, Department of Cardiology This link exits the ClinicalTrials.gov site
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:

  • Age 18 to 85 years old
  • Pulmonary Hypertension (PHTN) documented by Doppler echocardiography
  • Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's)
  • Able to sign informed consent
  • Patient being considered for Cardiothoracic Surgery

Exclusion Criteria:

  • Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90)
  • Active infection/sepsis
  • Creatinine greater than 3.0 mg/dl
  • LV ejection fraction < 40% (must be done with in the last 30 days prior to signing consent)
  • Significant valvular disease as a cause for the PHTN.
  • Severe Thrombocytopenia (as defined by platelets less than 20,000) or INR > 1.6
  • Hypersensitivity to nesiritide or any of it's components.
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 
Study Chair:     Daniel J. Lenihan, MD     M.D. Anderson Cancer Center    
Information Provided By M.D. Anderson Cancer Center
Verification Date March 2006
First Received Date  January 5, 2004
Last Updated Date March 28, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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