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Completed

NCT Number: NCT02734953

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

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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Key information

Conditions

Pulmonary Arterial Hypertension Behavior Hypertension, Pulmonary Lung Diseases Motor Activity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nitric oxide

Drug

Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test

Other names: iNOPulse DS

Primary outcomes

  1. 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

    Time frame: 2 hours

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

Secondary outcomes

  1. Change in CardioMems Cardiac Output

    Time frame: 2 hours

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

  2. Change in 6 Minute Walk Distance (6MWD)

    Time frame: 2 hours

    Difference (in distance walked between 2 set points over 6 minutes) at baseline (t=0) to post-intervention (t=2h).

  3. Change in O2 Saturations

    Time frame: 2 hours

  4. Change in Modified Borg Dyspnea Scale

    Time frame: 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).

  5. Change in O2 Requirements

    Time frame: 2 hours

    Number of patients that required more or less oxygen by nasal prongs during the course of the study.

  6. Change in Mean Arterial Pressure

    Time frame: 2 hours

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

  7. Change in Heart Rate

    Time frame: 2 hours

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

  8. Change in Rate Pressure Product

    Time frame: 2 hours

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

  9. Change in Right Ventricular (RV) Power

    Time frame: 2 hours

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

  10. Change in Stroke Volume

    Time frame: 2 hours

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

  11. Change in RV Stroke Work Index

    Time frame: 2 hours

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 12, 2016
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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