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

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ClinicalTrials.gov Identifier: NCT02734953
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Raymond Benza, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Nitric Oxide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension
Study Start Date : April 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: 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
Drug: Nitric Oxide
Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Other Name: iNOPulse DS




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734953


Locations
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United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Investigators
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Principal Investigator: Raymond L Benza, MD West Penn Allegheny Health System
Publications:
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Responsible Party: Raymond Benza, Physician, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier: NCT02734953    
Other Study ID Numbers: RC6167
First Posted: April 12, 2016    Key Record Dates
Results First Posted: September 24, 2018
Last Update Posted: September 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: With sponsor to provide statistical analysis
Keywords provided by Raymond Benza, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute):
Inhaled nitric oxide
Exercise
6 minute walk test
CardioMems
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents