Clinical trial NCT02734953: Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH
Official title: Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Keywords: Inhaled nitric oxide
Exercise
6 minute walk test
CardioMems
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
timeFrame: 2 hours
Secondary outcomes:
measure: Change in CardioMems Cardiac Output
timeFrame: 2 hours
measure: Change in 6 Minute Walk Distance (6MWD)
timeFrame: 2 hours
measure: Change in O2 Saturations
timeFrame: 2 hours
measure: Change in Modified Borg Dyspnea Scale
timeFrame: 2 hours
measure: Change in O2 Requirements
timeFrame: 2 hours
measure: Change in Mean Arterial Pressure
timeFrame: 2 hours
measure: Change in Heart Rate
timeFrame: 2 hours
measure: Change in Rate Pressure Product
timeFrame: 2 hours
measure: Change in Right Ventricular (RV) Power
timeFrame: 2 hours
measure: Change in Stroke Volume
timeFrame: 2 hours
measure: Change in RV Stroke Work Index
timeFrame: 2 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: Raymond L Benza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.