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Natrecor in Pulmonary Hypertension
This study has been terminated.
First Received: January 5, 2004   Last Updated: March 28, 2006   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00075179
  Purpose

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

MedlinePlus related topics: Cancer High Blood Pressure Pulmonary Hypertension Surgery
Drug Information available for: Nesiritide
U.S. FDA Resources
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

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 20
Study Start Date: January 2004
Estimated Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075179

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Daniel J. Lenihan, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: 2003-0562
Study First Received: January 5, 2004
Last Updated: March 28, 2006
ClinicalTrials.gov Identifier: NCT00075179     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Pulmonary hypertension
cancer
lung cancer
lung disease
cardiothoracic surgery
Nesiritide
Natrecor
CV Surgery
Lung Tumor

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Neoplasms
Lung Diseases
Vascular Diseases
Cardiovascular Agents
Hypertension

Additional relevant MeSH terms:
Natriuretic Peptide, Brain
Respiratory Tract Diseases
Natriuretic Agents
Hypertension, Pulmonary
Therapeutic Uses
Lung Diseases
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on May 06, 2009