Pulmonary Arterial HypertensionPhase 2NCT01165047
Nitric Oxide, GeNO Nitrosyl Delivery System
A Phase 2 study testing Nitric Oxide in people with Pulmonary Arterial Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
About this study
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
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.
Read more
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.
Read the 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 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Nitric Oxide
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called GeNO nitrosyl delivery system
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Boyle, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165047
- Sponsor's protocol ID
- 1.0
- Status last verified
- Aug 2014
- First submitted
- 16 Jul 2010
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01165047
- Acronym / sponsor ID
- 1.0
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Posted 1 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide | Experimental | Drug: Nitric Oxide80 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideAlso: GeNO nitrosyl delivery systemNitric 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. | Drug | Nitric Oxide |
Primary outcome
Number of Participants With Side Effects and/or Adverse Events
Time frame: 5 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Boyle, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide in people with Pulmonary Arterial Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Side Effects and/or Adverse Events (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.