Phase 2
N=10
Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02734953 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: 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 — -4.86; -2.40; -3.45 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nitric Oxide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-4.86; -2.40; -3.45 | — |
| SECONDARY Change in CardioMems Cardiac Output |
0.76 | — |
| SECONDARY Change in 6 Minute Walk Distance (6MWD) |
12.6 | — |
| SECONDARY Change in O2 Saturations |
-1 | — |
| SECONDARY Change in Modified Borg Dyspnea Scale |
-0.4 | — |
| SECONDARY Change in O2 Requirements |
— | — |
| SECONDARY Change in Mean Arterial Pressure |
-7 | — |
| SECONDARY Change in Heart Rate |
4 | — |
| SECONDARY Change in Rate Pressure Product |
316 | — |
| SECONDARY Change in Right Ventricular (RV) Power |
0.00685 | — |
| SECONDARY Change in Stroke Volume |
2.97 | — |
| SECONDARY Change in RV Stroke Work Index |
-1.80 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02734953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.