Natrecor for Pulmonary Hypertension in Lung Transplants

University of Wisconsin (UW)

Status and phase

Completed

Phase 4

Conditions

Pulmonary Hypertension

Treatments

Drug: Natrecor

Study type

Interventional

Funder types

Other

Identifiers

NCT00205426

H-2005-0185

Details and patient eligibility

About

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.

Full description

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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