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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitric Oxide
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Inhaled nitric oxide, Exercise, 6 minute walk test, CardioMems

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Allegheny General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in CardioMems Cardiac Output
Difference between baseline (t=0) and post-intervention (t=2h)
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).
Change in O2 Saturations
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).
Change in O2 Requirements
Number of patients that required more or less oxygen by nasal prongs during the course of the study.
Change in Mean Arterial Pressure
Difference between baseline (t=0) and post-intervention (t=2h).
Change in Heart Rate
Difference between baseline (t=0) and post-intervention (t=2h)
Change in Rate Pressure Product
Difference between baseline (t=0) and post-intervention (t=2h)
Change in Right Ventricular (RV) Power
Difference between baseline (t=0) and post-intervention (t=2h)
Change in Stroke Volume
Difference between baseline (t=0) and post-intervention (t=2h)
Change in RV Stroke Work Index
Difference between baseline (t=0) and post-intervention (t=2h)

Full Information

First Posted
March 26, 2016
Last Updated
August 24, 2018
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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1. Study Identification

Unique Protocol Identification Number
NCT02734953
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Inhaled nitric oxide, Exercise, 6 minute walk test, CardioMems

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Other Intervention Name(s)
iNOPulse DS
Intervention Description
Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Primary Outcome Measure Information:
Title
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
Description
Difference between baseline (t=0) and post-intervention (t=2h)
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Change in CardioMems Cardiac Output
Description
Difference between baseline (t=0) and post-intervention (t=2h)
Time Frame
2 hours
Title
Change in 6 Minute Walk Distance (6MWD)
Description
Difference (in distance walked between 2 set points over 6 minutes) at baseline (t=0) to post-intervention (t=2h).
Time Frame
2 hours
Title
Change in O2 Saturations
Time Frame
2 hours
Title
Change in Modified Borg Dyspnea Scale
Description
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
Title
Change in O2 Requirements
Description
Number of patients that required more or less oxygen by nasal prongs during the course of the study.
Time Frame
2 hours
Title
Change in Mean Arterial Pressure
Description
Difference between baseline (t=0) and post-intervention (t=2h).
Time Frame
2 hours
Title
Change in Heart Rate
Description
Difference between baseline (t=0) and post-intervention (t=2h)
Time Frame
2 hours
Title
Change in Rate Pressure Product
Description
Difference between baseline (t=0) and post-intervention (t=2h)
Time Frame
2 hours
Title
Change in Right Ventricular (RV) Power
Description
Difference between baseline (t=0) and post-intervention (t=2h)
Time Frame
2 hours
Title
Change in Stroke Volume
Description
Difference between baseline (t=0) and post-intervention (t=2h)
Time Frame
2 hours
Title
Change in RV Stroke Work Index
Description
Difference between baseline (t=0) and post-intervention (t=2h)
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond L Benza, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
With sponsor to provide statistical analysis
Citations:
PubMed Identifier
18582809
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.
Results Reference
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PubMed Identifier
10790348
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.
Results Reference
background
PubMed Identifier
24816520
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.
Results Reference
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Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH

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