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Home > "N" Clinical Trials Conditions > Natrecor in Pulmonary Hypertension  Natrecor in Pulmonary Hypertension
Natrecor in Pulmonary Hypertension
For Condition: Pulmonary Hypertension,Cancer,Lung Disease,Cardiothoracic Surgery
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
DanielLenihan, Study Chair, M.D. Anderson Cancer Center
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Additional Information:
Study ID Numbers: 2003-0562;
Study Start Date: January 2004
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075179
Other Lung Disease Studies:
1. Evaluation and Treatment of Patients with Lung Disease not Participating in Research
2. Study of the Disease Process of Lymphangioleiomyomatosis
3. Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
4. An Open-Label Study of the Safety of Interferon gamma-1b in Patients with IPF
5. The INSPIRE Trial: A Study of Interferon gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)
Related Studies:
Other Lung Disease Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Natrecor in Pulmonary Hypertension
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