Nitric Oxide, GeNO Nitrosyl Delivery System

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aurora Health Care
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• An Institutional Review board (IRB) approved informed consent is signed, dated and timed prior to any study-related activities.

• Male or female > 18 years of age.

• Being evaluated for OHT or LVAD implantation and scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity.

• Have a confirmed diagnosis of heart failure, (NYHA Class III or IV)

• Participant has the ability to understand the requirements of the study and a willingness to comply with all study procedures.

• Females of childbearing potential with a negative urine pregnancy test, or a documented surgical sterilization, or is post-menopausal prior to administration of investigational product. Females of childbearing potential must be practicing adequate birth control to be eligible. It is the Investigator's responsibility to determine whether the Participant has adequate birth control for study participation.

• Confirmed pulmonary arterial hypertension at time of RHC:

• PAPm > 25mmHg at rest and PVR > 3 Wood units

Exclusion Criteria:

• Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.

• Have had an atrial septostomy.

• Have anemia (hemoglobin <10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.

• Have any serious or life-threatening disease other than conditions (e.g. malignancy requiring aggressive chemotherapy, etc.).

• Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial, or any condition, which in the investigator's opinion would constitute an unacceptable risk to the participant's safety.

• Participant is pregnant or lactating