Pulmonary Arterial HypertensionPhase 2NCT02734953
Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH
A Phase 2 study testing Nitric Oxide in people with Pulmonary Arterial Hypertension, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
Pulmonary hypertension is characterized by an increase in the pressures in the blood supply to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall pulmonary vascular resistance (PVR). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- 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
- Apr 2016to Dec 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females age 18 to 80 years with a diagnosis of pulmonary arterial hypertension (WHO Group I pulmonary hypertension).
- Must be able to read and understand English and consent for themselves
- Previously implanted CardioMems continuous PA pressure
- Ambulatory and able to complete 6MWD test.
Who cannot join
- Pregnant or lactating females; negative pregnancy test as confirmed by evaluation of data from pre-enrolled Risk Evaluation and Mitigation Strategies (REMS) program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension
Pulmonary hypertension is characterized by an increase in the pressures in the blood supply to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary vasculature, PVR will increase with exercise instead of decreasing as it would in normal patients. Based on published evidence, the investigators intend to investigate the effects of inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have separately and previously had an implanted pulmonary artery monitoring device (CardioMems by St Jude Medical, Inc.) placed.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Nitric Oxide
- Keywords
- Inhaled nitric oxide, Exercise, 6 minute walk test, CardioMems
- Medical subject headings
- Pulmonary Arterial Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called iNOPulse DS
Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Receives: Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device
Difference between baseline (t=0) and post-intervention (t=2h)
Measured: 2 hours
Secondary outcomes (11)
Change in CardioMems Cardiac Output
Difference between baseline (t=0) and post-intervention (t=2h)
Measured: 2 hours
Change in 6 Minute Walk Distance (6MWD)
Difference (in distance walked between 2 set points over 6 minutes) at baseline (t=0) to post-intervention (t=2h).
Measured: 2 hours
Change in O2 Saturations
Measured: 2 hours
Change in Modified Borg Dyspnea Scale
The Modified Borg Dyspnea scale measures patient's subjective analysis of dyspnea from 0 ("nothing at all") to 10 ("maximal") during the 6MWD test with the highest value recorded and difference calculated between baseline (t=0) and post-intervention (t=2h).
Measured: 2 hours
Change in O2 Requirements
Number of patients that required more or less oxygen by nasal prongs during the course of the study.
Measured: 2 hours
Change in Mean Arterial Pressure
Difference between baseline (t=0) and post-intervention (t=2h).
Measured: 2 hours
Change in Heart Rate
Difference between baseline (t=0) and post-intervention (t=2h)
Measured: 2 hours
Change in Rate Pressure Product
Difference between baseline (t=0) and post-intervention (t=2h)
Measured: 2 hours
Change in Right Ventricular (RV) Power
Difference between baseline (t=0) and post-intervention (t=2h)
Measured: 2 hours
Change in Stroke Volume
Difference between baseline (t=0) and post-intervention (t=2h)
Measured: 2 hours
Change in RV Stroke Work Index
Difference between baseline (t=0) and post-intervention (t=2h)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016
- Study completionDec 2016
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Benza, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Raymond L Benza, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734953
- Sponsor's protocol ID
- RC6167
- Status last verified
- Aug 2018
- First submitted
- 26 Mar 2016
- Last updated
- 24 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: With sponsor to provide statistical analysis
Publications
Frantz RP, Benza RL, Kjellstrom B, Bourge RC, Barst RJ, Bennett TD, McGoon MD. Continuous hemodynamic monitoring in patients with pulmonary arterial hypertension. J Heart Lung Transplant. 2008 Jul;27(7):780-8. doi: 10.1016/j.healun.2008.04.009. Epub 2008 Jun 2.
PubMed 18582809Hasuda T, Satoh T, Shimouchi A, Sakamaki F, Kyotani S, Matsumoto T, Goto Y, Nakanishi N. Improvement in exercise capacity with nitric oxide inhalation in patients with precapillary pulmonary hypertension. Circulation. 2000 May 2;101(17):2066-70. doi: 10.1161/01.cir.101.17.2066.
PubMed 10790348Kjellstrom B, Frantz RP, Benza RL, Bennett T, Bourge RC, McGoon MD. Hemodynamic ranges during daily activities and exercise testing in patients with pulmonary arterial hypertension. J Card Fail. 2014 Jul;20(7):485-91. doi: 10.1016/j.cardfail.2014.04.019. Epub 2014 May 9.
PubMed 24816520
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02734953
- Acronym / sponsor ID
- RC6167
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Inhaled nitric oxide, Exercise, 6 minute walk test, CardioMems
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 24 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulmonary hypertension is characterized by an increase in the pressures in the blood supply to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary vasculature, PVR will increase with exercise instead of decreasing as it would in normal patients. Based on published evidence, the investigators intend to investigate the effects of inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have separately and previously had an implanted pulmonary artery monitoring device (CardioMems by St Jude Medical, Inc.) placed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Nitric OxideDetermination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females age 18 to 80 years with a diagnosis of pulmonary arterial hypertension (WHO Group I pulmonary hypertension).
- Must be able to read and understand English and consent for themselves
- Previously implanted CardioMems continuous PA pressure
- Ambulatory and able to complete 6MWD test.
Key exclusion criteria (1 listed)
- Pregnant or lactating females; negative pregnancy test as confirmed by evaluation of data from pre-enrolled Risk Evaluation and Mitigation Strategies (REMS) program.
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: iNOPulse DSAmbulatory inhaled nitric oxide delivery system and 6 minute walk distance test | Drug | Intervention |
Primary outcome
Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device
Time frame: 2 hours
Difference between baseline (t=0) and post-intervention (t=2h)
11 secondary outcomes
Change in CardioMems Cardiac Output
Time frame: 2 hours
Change in 6 Minute Walk Distance (6MWD)
Time frame: 2 hours
Change in O2 Saturations
Time frame: 2 hours
Change in Modified Borg Dyspnea Scale
Time frame: 2 hours
Change in O2 Requirements
Time frame: 2 hours
Change in Mean Arterial Pressure
Time frame: 2 hours
Change in Heart Rate
Time frame: 2 hours
Change in Rate Pressure Product
Time frame: 2 hours
Change in Right Ventricular (RV) Power
Time frame: 2 hours
Change in Stroke Volume
Time frame: 2 hours
Change in RV Stroke Work Index
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18582809Frantz RP, Benza RL, Kjellstrom B, Bourge RC, Barst RJ, Bennett TD, McGoon MD. Continuous hemodynamic monitoring in patients with pulmonary arterial hypertension. J Heart Lung Transplant. 2008 Jul;27(7):780-8. doi: 10.1016/j.healun.2008.04.009. Epub 2008 Jun 2.
- Background: PubMed 10790348Hasuda T, Satoh T, Shimouchi A, Sakamaki F, Kyotani S, Matsumoto T, Goto Y, Nakanishi N. Improvement in exercise capacity with nitric oxide inhalation in patients with precapillary pulmonary hypertension. Circulation. 2000 May 2;101(17):2066-70. doi: 10.1161/01.cir.101.17.2066.
- Background: PubMed 24816520Kjellstrom B, Frantz RP, Benza RL, Bennett T, Bourge RC, McGoon MD. Hemodynamic ranges during daily activities and exercise testing in patients with pulmonary arterial hypertension. J Card Fail. 2014 Jul;20(7):485-91. doi: 10.1016/j.cardfail.2014.04.019. Epub 2014 May 9.
- Individual participant dataSharing planned: Yes. With sponsor to provide statistical analysis
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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.
Raymond L Benza, MD principal investigator
West Penn Allegheny Health System
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 Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) 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 4 inclusion and 1 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 24 Sep 2018. 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 24 Sep 2018). 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?
Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734953, which also lists 3 linked publications.
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 24 Sep 2018.