Nitric Oxide, GeNO Nitrosyl Delivery System

NCT01165047 | Completed Phase 2 Results DMC

• 1 other identifier: 1.0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Side Effects and/or Adverse Events

  A phone contact will be made to the subject 5 days after the trial to assess general health status and collect information on any reported side effects or adverse events.

  5 days

Study Arms (1)

Nitric Oxide

EXPERIMENTAL

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

Drug: Nitric Oxide

Interventions

Nitric Oxide DRUG

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.

Also known as: GeNO nitrosyl delivery system

Nitric Oxide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Results Point of Contact

• Title: Katernie Slotke
• Organization: Aurora Health Care

katherine.Slotke@aurora.org

414-649-2615

Study Officials

• Andrew Boyle, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 19, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 3, 2024
• Results First Posted: September 1, 2014

Record last verified: 2014-08

Locations

US (1)