Effect of Short-term Oxygen During CPET in Pulmonary Hypertension

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

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-07-31

Brief Summary

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In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension.

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Detailed Description

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Conditions

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Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension Chronic Cardiorespiratory Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Supplemental oxygen

Supplemental oxygen will be applied via a mask during CPET

Group Type EXPERIMENTAL

Supplemental oxygen via a mask

Intervention Type PROCEDURE

Sham room air

Room air will be applied similarly to oxygen

Group Type PLACEBO_COMPARATOR

Supplemental oxygen via a mask

Intervention Type PROCEDURE

Interventions

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Supplemental oxygen via a mask

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of pulmonary arterial 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 week
* desaturate in the 6 minute walking test by at least 4% to values \<92%

Exclusion Criteria

* unstable conditions
* pregnant women
* patients with pulmonary venous hypertension
* patients with relevant concomitant lung disease and severe daytime hypoxemia

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No