Natrecor in Pulmonary Hypertension

• Status: Terminated
• Trial end date: 2006-03-28
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs.

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

1. Ages 18 to 85 years old.

2. Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's).

3. PHTN documented by Doppler Echocardiography ( Done with in last 30 days)

4. Must be able to give an informed consent.

Exclusion Criteria:

1. Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90).

2. Active infection or sepsis as defined by fever and need for IV antibiotics.

3. Creatinine greater than 3.0 mg/dl

4. Significant valvular disease as a cause for the PHTN.

5. Severe Thrombocytopenia (as defined by platelets less than 20,000 or INR > 1.6.

6. Left Ventricle Ejection Fraction (LVEF) <40% (must be done with in the last 30 days prior to signing consent).

7. Hypersensitivity to nesiritide or any of it's components.