Natrecor for Pulmonary Hypertension in Lung Transplants
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2005 |
| End Date: | May 2006 |
Natrecor® (Nesiritide) as a Nitric Oxide Sparing Agent in Patients Undergoing Lung Transplantation
This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a
favorable hemodynamic profile in lung transplant recipients that will allow for the
avoidance of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide will
decrease the otherwise historically mandated use of iNO by 50%, as compared to the necessity
of iNO use by matched historical controls.
favorable hemodynamic profile in lung transplant recipients that will allow for the
avoidance of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide will
decrease the otherwise historically mandated use of iNO by 50%, as compared to the necessity
of iNO use by matched historical controls.
A condition called ischemic reperfusion injury (IRI) occurs in all lung transplants. The
amount of reperfusion injury varies from person to person. IRI occurs when the blood supply
to tissue (in this case, transplanted lung(s)) is decreased and then is restored. IRI can
cause a decrease in function in a newly transplanted lung. When this occurs, or when people
have pulmonary hypertension (high blood pressure in your lungs), doctors use Nitric Oxide to
improve the pressure and blood supply to the transplanted lung. Nitric Oxide (NO) is given
by inhalation while patients are on a ventilator (breathing machine). Because NO must be
given by a ventilator and because patients on ventilators must be in an intensive care unit,
the cost of treating people with NO is very high. NO can also cause rebound pulmonary
hypertension (high blood pressure in the lungs that reoccurs) when it is stopped. Because of
these reasons, doctors are looking for other treatments for IRI and pulmonary hypertension.
A drug called Natrecor has been shown to reduce pulmonary pressures in heart transplant
patients. Doctors believe it may be helpful to lung transplant patients as well.
amount of reperfusion injury varies from person to person. IRI occurs when the blood supply
to tissue (in this case, transplanted lung(s)) is decreased and then is restored. IRI can
cause a decrease in function in a newly transplanted lung. When this occurs, or when people
have pulmonary hypertension (high blood pressure in your lungs), doctors use Nitric Oxide to
improve the pressure and blood supply to the transplanted lung. Nitric Oxide (NO) is given
by inhalation while patients are on a ventilator (breathing machine). Because NO must be
given by a ventilator and because patients on ventilators must be in an intensive care unit,
the cost of treating people with NO is very high. NO can also cause rebound pulmonary
hypertension (high blood pressure in the lungs that reoccurs) when it is stopped. Because of
these reasons, doctors are looking for other treatments for IRI and pulmonary hypertension.
A drug called Natrecor has been shown to reduce pulmonary pressures in heart transplant
patients. Doctors believe it may be helpful to lung transplant patients as well.
Inclusion Criteria:
- Single or double lung transplant or heart/lung transplant recipient
- Planned use of Natrecor
- Pulmonary artery (PA) systolic pressures > 35
Exclusion Criteria:
- Previous lung transplant
- Use of Prolastin after pneumonectomy
- Mean arterial pressure of < 55
- Known allergy or sensitivity to nesiritide
- Females of childbearing potential with a positive pregnancy test or women who are
breast feeding
- Use of nesiritide, for any reason, within 30 days prior to transplant
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
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