Nitric Oxide, GeNO Nitrosyl Delivery System

Status Completed

Clinical Trial 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.

Clinical Trial 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 drug/device 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 participant's clinical needs for supplemental oxygen. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01165047
Study type	Interventional
Source	Aurora Health Care
Contact
Status	Completed
Phase	Phase 2
Start date	September 2010
Completion date	September 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04076241` - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension	N/A
Completed	`NCT05521113` - Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Recruiting	`NCT04972656` - Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension	N/A
Completed	`NCT04908397` - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension	Phase 1
Active, not recruiting	`NCT03288025` - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)	N/A
Completed	`NCT01959815` - Novel Screening Strategies for Scleroderma PAH
Recruiting	`NCT04266197` - Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study	Phase 2
Active, not recruiting	`NCT06092424` - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)	N/A
Enrolling by invitation	`NCT03683186` - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension	Phase 3
Terminated	`NCT02060487` - Effects of Oral Sildenafil on Mortality in Adults With PAH	Phase 4
Terminated	`NCT02253394` - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study	Phase 4
Withdrawn	`NCT02958358` - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan	N/A
Terminated	`NCT01953965` - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.	Phase 2
Withdrawn	`NCT01723371` - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children	Phase 1/Phase 2
Unknown status	`NCT01712997` - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients	Phase 3
Not yet recruiting	`NCT01649739` - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost	Phase 4
Completed	`NCT01548950` - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension	N/A
Completed	`NCT00942708` - Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension	Phase 2
Completed	`NCT00963027` - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil	Phase 1
Completed	`NCT00963001` - Effect of Food on the Pharmacokinetics of Oral Treprostinil	Phase 1