Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884012
• Other study ID #: KEK 2012-0538
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2013
• Last updated: May 4, 2017
• Start date: May 2013
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

Intervention

Procedure:
• long term oxygen therapy

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Pneumology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test	6 minute walk distance according to american thoracic society (ATS) guidelines	5 weeks
Primary	Quality of life	QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale	5 weeks
Secondary	Daily activity	measured by actigraphy	5 week
Secondary	hemodynamics by echocardiography	Full echocardiographic assessment	5 weeks
Secondary	quality of life	SF-36	5 weeks
Secondary	arterial blood gas	partial pressure of oxygen (PaO2)	5 weeks
Secondary	operating hours of oxygen concentrator	efficacy of oxygen treatment	5 weeks
Secondary	mean nocturnal oxygen saturation	Ambulatory Sleep Study	5 weeks
Secondary	tests of cognitive performance	STROOP-Test	5 weeks
Secondary	Quality of life	Minnesota living with heart failure questionnaire	5 weeks
Secondary	Venous blood	N-terminal brain natriuretic peptide (NT-proBNP)	5 weeks