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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01884012

Enrollment

Registered

2013-06-21

Start date

2013-05-31

Completion date

2017-03-31

Last updated

2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

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.

Interventions

PROCEDURElong term oxygen therapy

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
6 minute walk test	5 weeks	6 minute walk distance according to american thoracic society (ATS) guidelines
Quality of life	5 weeks	QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale

Secondary

Measure	Time frame	Description
Daily activity	5 week	measured by actigraphy
hemodynamics by echocardiography	5 weeks	Full echocardiographic assessment
quality of life	5 weeks	SF-36
arterial blood gas	5 weeks	partial pressure of oxygen (PaO2)
operating hours of oxygen concentrator	5 weeks	efficacy of oxygen treatment
mean nocturnal oxygen saturation	5 weeks	Ambulatory Sleep Study
tests of cognitive performance	5 weeks	STROOP-Test
Quality of life	5 weeks	Minnesota living with heart failure questionnaire
Venous blood	5 weeks	N-terminal brain natriuretic peptide (NT-proBNP)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026