The primary aim of the study is to evaluate the safety, tolerability and device performance
of the GeNO nitrosyl delivery system during RHC. Secondary considerations are to confirm that
inhaled NO generated by the GeNO nitrosyl delivery system, reduces PVR in patients with
reversible PH, contains levels of NO2 well below the upper level of acceptable exposure.
Further, the study aims to demonstrate that patient response to inhaled NO can be used as a
diagnostic tool with which to determine the proper course of medical action in patients with
chronic heart failure.
Patients with chronic heart failure accompanied by pulmonary hypertension and increased
pulmonary vascular resistance have a number of possible medical therapies available to them.
The least invasive, and therefore most appealing, option is standard management with
medication and observation. Alternatively, implantation of a left ventricular assist device
(LVAD) may be considered, either as a permanent solution or as a bridging strategy to the
final option, orthotopic heart transplantation (OHT). It is often unclear which route is the
best medical choice, and a tool to help physicians and patients choose between these
alternatives would be greatly beneficial.
It has been shown that chronic heart failure patients that demonstrate irreversible pulmonary
hypertension, even in the presence of vasodilators, exhibit adverse outcomes after OHT (Tsai
et al., 2002; Ericson et al., 1990; Murali et al., 1996). It follows that patient response to
pulmonary vasodilators can, and should be used to classify patients as potential candidates
for OHT. In particular, patient response to inhaled NO, a known pulmonary vasodilator, can be
used as a diagnostic tool to assist in deciding which medical route to take.
With this in mind, the current study aims to demonstrate whether or not NO generated by the
GeNO nitrosyl delivery system effects a reduction in pulmonary hypertension due to increased
pulmonary vascular resistance in patients with chronic heart failure. Any demonstrated
ability of inhaled NO to decrease PVR in patients with reversible PH will support the use of
patient response to inhaled NO as a diagnostic tool to assist in choosing the most
appropriate medical therapy for patients with chronic heart failure.