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

NCT ID: NCT01884012

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Supplemental oxygen

Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day

Group Type EXPERIMENTAL

long term oxygen therapy

Intervention Type PROCEDURE

Sham room air

Room air given at a flow rate of 3 liters per minute for 16 hours a day

Group Type SHAM_COMPARATOR

long term oxygen therapy

Intervention Type PROCEDURE

Interventions

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long term oxygen therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvia Ulrich Somaini, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Pneumology

Locations

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University Hospital Zurich, Division of Pneumology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK 2012-0538

Identifier Type: -

Identifier Source: org_study_id

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