Pulmonary Arterial Hypertension
Conditions
Keywords
Inhaled nitric oxide, Exercise, 6 minute walk test, CardioMems
Brief 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). 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.
Interventions
DRUGNitric Oxide
Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Pregnant or lactating females; negative pregnancy test as confirmed by evaluation of data from pre-enrolled Risk Evaluation and Mitigation Strategies (REMS) program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 hours | Difference between baseline (t=0) and post-intervention (t=2h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 Minute Walk Distance (6MWD) | 2 hours | Difference (in distance walked between 2 set points over 6 minutes) at baseline (t=0) to post-intervention (t=2h). |
| Change in O2 Saturations | 2 hours | — |
| Change in Modified Borg Dyspnea Scale | 2 hours | 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). |
| Change in O2 Requirements | 2 hours | Number of patients that required more or less oxygen by nasal prongs during the course of the study. |
| Change in Mean Arterial Pressure | 2 hours | Difference between baseline (t=0) and post-intervention (t=2h). |
| Change in CardioMems Cardiac Output | 2 hours | Difference between baseline (t=0) and post-intervention (t=2h) |
| Change in Rate Pressure Product | 2 hours | Difference between baseline (t=0) and post-intervention (t=2h) |
| Change in Right Ventricular (RV) Power | 2 hours | Difference between baseline (t=0) and post-intervention (t=2h) |
| Change in Stroke Volume | 2 hours | Difference between baseline (t=0) and post-intervention (t=2h) |
| Change in RV Stroke Work Index | 2 hours | Difference between baseline (t=0) and post-intervention (t=2h) |
| Change in Heart Rate | 2 hours | Difference between baseline (t=0) and post-intervention (t=2h) |
Countries
United States
Participant flow
Recruitment details
Recruitment period: June 1-25, 2016 Recruitment Location: medical clinic
Pre-assignment details
All enrolled participants were included,
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Intervention | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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)
Time frame: 2 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | 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 | PA pressure systolic | -4.86 mmHg |
| Intervention | 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 | PA pressure diastolic | -2.40 mmHg |
| Intervention | 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 | PA pressure mean | -3.45 mmHg |
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).
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in 6 Minute Walk Distance (6MWD) | 12.6 m |
Secondary
Change in CardioMems Cardiac Output
Difference between baseline (t=0) and post-intervention (t=2h)
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in CardioMems Cardiac Output | 0.76 L/min |
Secondary
Change in Heart Rate
Difference between baseline (t=0) and post-intervention (t=2h)
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Heart Rate | 4 bpm |
Secondary
Change in Mean Arterial Pressure
Difference between baseline (t=0) and post-intervention (t=2h).
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Mean Arterial Pressure | -7 mmHg |
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).
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Modified Borg Dyspnea Scale | -0.4 units on a scale |
Secondary
Change in O2 Requirements
Number of patients that required more or less oxygen by nasal prongs during the course of the study.
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Change in O2 Requirements | 0 participants |
Secondary
Change in O2 Saturations
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in O2 Saturations | -1 % O2 Sat |
Secondary
Change in Rate Pressure Product
Difference between baseline (t=0) and post-intervention (t=2h)
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Rate Pressure Product | 316 mmHg*beat/min |
Secondary
Change in Right Ventricular (RV) Power
Difference between baseline (t=0) and post-intervention (t=2h)
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Right Ventricular (RV) Power | 0.00685 J/s |
Secondary
Change in RV Stroke Work Index
Difference between baseline (t=0) and post-intervention (t=2h)
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in RV Stroke Work Index | -1.80 g*m/m2 |
Secondary
Change in Stroke Volume
Difference between baseline (t=0) and post-intervention (t=2h)
Time frame: 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Stroke Volume | 2.97 mL |