Back to resultsEffect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Primary Purpose
Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
long term oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Eligibility Criteria
Inclusion criteria:
- Adult patients with established diagnosis of pulmonary arterial or chronic thromboembolic pulmonary hypertension (class I and IV according to the latest WHO classification scheme of Dana Point 2008) on optimized medical therapy and in stable condition for at least 4 weeks, who desaturate in the 6 minute walking test by =4% to values <92%.
Exclusion criteria:
- Patients in unstable conditions requiring frequent therapeutic adaption
- pregnant women
- patients with pulmonary venous hypertension due to left heart diseases
- patients with relevant concomitant lung disease and severe daytime hypoxemia
Sites / Locations
- University Hospital Zurich, Division of Pneumology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Supplemental oxygen
Sham room air
Arm Description
Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day
Room air given at a flow rate of 3 liters per minute for 16 hours a day
Outcomes
Primary Outcome Measures
6 minute walk test
6 minute walk distance according to american thoracic society (ATS) guidelines
Quality of life
QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale
Secondary Outcome Measures
Daily activity
measured by actigraphy
hemodynamics by echocardiography
Full echocardiographic assessment
quality of life
SF-36
arterial blood gas
partial pressure of oxygen (PaO2)
operating hours of oxygen concentrator
efficacy of oxygen treatment
mean nocturnal oxygen saturation
Ambulatory Sleep Study
tests of cognitive performance
STROOP-Test
Quality of life
Minnesota living with heart failure questionnaire
Venous blood
N-terminal brain natriuretic peptide (NT-proBNP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01884012
Brief Title
Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this randomized-controlled, cross-over trial the investigators test the effect of long-term oxygen therapy (> 16h/day) given for 5 weeks with a wash-out period between phases of 2 weeks on exercise performance and quality of life and many physiological parameters in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supplemental oxygen
Arm Type
Experimental
Arm Description
Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day
Arm Title
Sham room air
Arm Type
Sham Comparator
Arm Description
Room air given at a flow rate of 3 liters per minute for 16 hours a day
Intervention Type
Procedure
Intervention Name(s)
long term oxygen therapy
Primary Outcome Measure Information:
Title
6 minute walk test
Description
6 minute walk distance according to american thoracic society (ATS) guidelines
Time Frame
5 weeks
Title
Quality of life
Description
QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Daily activity
Description
measured by actigraphy
Time Frame
5 week
Title
hemodynamics by echocardiography
Description
Full echocardiographic assessment
Time Frame
5 weeks
Title
quality of life
Description
SF-36
Time Frame
5 weeks
Title
arterial blood gas
Description
partial pressure of oxygen (PaO2)
Time Frame
5 weeks
Title
operating hours of oxygen concentrator
Description
efficacy of oxygen treatment
Time Frame
5 weeks
Title
mean nocturnal oxygen saturation
Description
Ambulatory Sleep Study
Time Frame
5 weeks
Title
tests of cognitive performance
Description
STROOP-Test
Time Frame
5 weeks
Title
Quality of life
Description
Minnesota living with heart failure questionnaire
Time Frame
5 weeks
Title
Venous blood
Description
N-terminal brain natriuretic peptide (NT-proBNP)
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
- Adult patients with established diagnosis of pulmonary arterial or chronic thromboembolic pulmonary hypertension (class I and IV according to the latest WHO classification scheme of Dana Point 2008) on optimized medical therapy and in stable condition for at least 4 weeks, who desaturate in the 6 minute walking test by =4% to values <92%.
Exclusion criteria:
Patients in unstable conditions requiring frequent therapeutic adaption
pregnant women
patients with pulmonary venous hypertension due to left heart diseases
patients with relevant concomitant lung disease and severe daytime hypoxemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich Somaini, MD
Organizational Affiliation
University Hospital Zurich, Division of Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Pneumology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
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