Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Change in CardioMems Cardiac Output

Difference between baseline (t=0) and post-intervention (t=2h)

Time frame: 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).

Time frame: 2 hours

Change in O2 Saturations

Time frame: 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).

Time frame: 2 hours

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

Change in Mean Arterial Pressure

Difference between baseline (t=0) and post-intervention (t=2h).

Time frame: 2 hours

Change in Heart Rate

Difference between baseline (t=0) and post-intervention (t=2h)

Time frame: 2 hours

Change in Rate Pressure Product

Difference between baseline (t=0) and post-intervention (t=2h)

Time frame: 2 hours

Change in Right Ventricular (RV) Power

Difference between baseline (t=0) and post-intervention (t=2h)

Time frame: 2 hours

Change in Stroke Volume

Difference between baseline (t=0) and post-intervention (t=2h)

Time frame: 2 hours

Change in RV Stroke Work Index

Difference between baseline (t=0) and post-intervention (t=2h)

Time frame: 2 hours

Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes