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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide | Drug | Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CardioMems Cardiac Output | Difference between baseline (t=0) and post-intervention (t=2h) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond L Benza, MD | West Penn Allegheny Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18582809 | Background | 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. | |
| 10790348 | Background | Hasuda 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. |
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With sponsor to provide statistical analysis
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All enrolled participants were included,
Recruitment period: June 1-25, 2016 Recruitment Location: medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 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 Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 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 Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Full Range | mmHg | 2 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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 Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Raymond Benza | Allegheny Health Network | 412-359-3131 | raymond.benza@ahn.org |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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| 2 hours |
| Change in O2 Saturations | 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). | 2 hours |
| Change in O2 Requirements | Number of patients that required more or less oxygen by nasal prongs during the course of the study. | 2 hours |
| Change in Mean Arterial Pressure | Difference between baseline (t=0) and post-intervention (t=2h). | 2 hours |
| Change in Heart Rate | Difference between baseline (t=0) and post-intervention (t=2h) | 2 hours |
| Change in Rate Pressure Product | Difference between baseline (t=0) and post-intervention (t=2h) | 2 hours |
| Change in Right Ventricular (RV) Power | Difference between baseline (t=0) and post-intervention (t=2h) | 2 hours |
| Change in Stroke Volume | Difference between baseline (t=0) and post-intervention (t=2h) | 2 hours |
| Change in RV Stroke Work Index | Difference between baseline (t=0) and post-intervention (t=2h) | 2 hours |
| 24816520 | Background | Kjellstrom 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Change in CardioMems Cardiac Output | Difference between baseline (t=0) and post-intervention (t=2h) | Posted | Mean | Full Range | L/min | 2 hours |
|
|
|
| Secondary | 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). | Posted | Mean | Full Range | m | 2 hours |
|
|
|
| Secondary | Change in O2 Saturations | Posted | Mean | Full Range | % O2 Sat | 2 hours |
|
|
|
| Secondary | 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). | Posted | Mean | Full Range | units on a scale | 2 hours |
|
|
|
| Secondary | Change in O2 Requirements | Number of patients that required more or less oxygen by nasal prongs during the course of the study. | Posted | Number | participants | 2 hours |
|
|
|
| Secondary | Change in Mean Arterial Pressure | Difference between baseline (t=0) and post-intervention (t=2h). | Posted | Mean | Full Range | mmHg | 2 hours |
|
|
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| Secondary | Change in Heart Rate | Difference between baseline (t=0) and post-intervention (t=2h) | Posted | Mean | Full Range | bpm | 2 hours |
|
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| Secondary | Change in Rate Pressure Product | Difference between baseline (t=0) and post-intervention (t=2h) | Posted | Mean | Full Range | mmHg*beat/min | 2 hours |
|
|
|
| Secondary | Change in Right Ventricular (RV) Power | Difference between baseline (t=0) and post-intervention (t=2h) | Posted | Mean | Full Range | J/s | 2 hours |
|
|
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| Secondary | Change in Stroke Volume | Difference between baseline (t=0) and post-intervention (t=2h) | Posted | Mean | Full Range | mL | 2 hours |
|
|
|
| Secondary | Change in RV Stroke Work Index | Difference between baseline (t=0) and post-intervention (t=2h) | Posted | Mean | Full Range | g*m/m2 | 2 hours |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
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| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |