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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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ClinicalTrials.gov Identifier: NCT01884012
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension Procedure: long term oxygen therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017


Arm Intervention/treatment
Experimental: Supplemental oxygen
Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day
Procedure: long term oxygen therapy
Sham Comparator: Sham room air
Room air given at a flow rate of 3 liters per minute for 16 hours a day
Procedure: long term oxygen therapy



Primary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 5 weeks ]
    6 minute walk distance according to american thoracic society (ATS) guidelines

  2. Quality of life [ Time Frame: 5 weeks ]
    QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale


Secondary Outcome Measures :
  1. Daily activity [ Time Frame: 5 week ]
    measured by actigraphy

  2. hemodynamics by echocardiography [ Time Frame: 5 weeks ]
    Full echocardiographic assessment

  3. quality of life [ Time Frame: 5 weeks ]
    SF-36

  4. arterial blood gas [ Time Frame: 5 weeks ]
    partial pressure of oxygen (PaO2)

  5. operating hours of oxygen concentrator [ Time Frame: 5 weeks ]
    efficacy of oxygen treatment

  6. mean nocturnal oxygen saturation [ Time Frame: 5 weeks ]
    Ambulatory Sleep Study

  7. tests of cognitive performance [ Time Frame: 5 weeks ]
    STROOP-Test

  8. Quality of life [ Time Frame: 5 weeks ]
    Minnesota living with heart failure questionnaire

  9. Venous blood [ Time Frame: 5 weeks ]
    N-terminal brain natriuretic peptide (NT-proBNP)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01884012


Locations
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Switzerland
University Hospital Zurich, Division of Pneumology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Silvia Ulrich Somaini, MD University Hospital Zurich, Division of Pneumology

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01884012    
Other Study ID Numbers: KEK 2012-0538
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases