Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01165047
Status:
COMPLETED
Last Update Posted:
2014-09-01
First Post:
2010-07-16
Brief Title:
Nitric Oxide GeNO Nitrosyl Delivery System
Sponsor:
Aurora Health Care
Organization:
Aurora Health Care
Study Overview
Official Title:
An Open Label Non-Randomized Pilot Study to Evaluate the Safety and Performance of the GeNO Nitrosyl Delivery System in Subjects Being Evaluated for Orthotopic Heart Transplantation OHT or Left Ventricular Assist Device LVAD Implantation
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Investigational product will be administered by qualified study staff in accordance with the procedures described in the protocol and in accordance with the detailed set of instructions supplied with the initial shipment of investigational product
Nitric oxide 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM
In order to reliably measure trace levels of NO2 in the presence of a large excess of NO it is essential to use a technique with extremely high accuracy in situations of low levels of NO2 The GeNO nitrosyl delivery system delivers a fixed concentration of 80ppm NO with low levels of NO2 which current technology cannot measure with accuracy at levels below 3ppm
The investigational product is the GeNO nitrosyl delivery system which consists of a drugdevice combination product with all the components necessary to deliver the investigational drug the nitric oxide gas The investigational drug nitric oxide is generated at the time of use when the NO2 input gas flows through the cartridge the antioxidant reduces the NO2 to NO
The input gas is supplied as either nitric oxide in air or nitric oxide in oxygen The Investigator will determine whether air or oxygen is used as the balance gas on the basis of the participants clinical needs for supplemental oxygen
Nitric oxide 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM
In order to reliably measure trace levels of NO2 in the presence of a large excess of NO it is essential to use a technique with extremely high accuracy in situations of low levels of NO2 The GeNO nitrosyl delivery system delivers a fixed concentration of 80ppm NO with low levels of NO2 which current technology cannot measure with accuracy at levels below 3ppm
The investigational product is the GeNO nitrosyl delivery system which consists of a drugdevice combination product with all the components necessary to deliver the investigational drug the nitric oxide gas The investigational drug nitric oxide is generated at the time of use when the NO2 input gas flows through the cartridge the antioxidant reduces the NO2 to NO
The input gas is supplied as either nitric oxide in air or nitric oxide in oxygen The Investigator will determine whether air or oxygen is used as the balance gas on the basis of the participants clinical needs for supplemental oxygen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None