Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)

University of Zurich40 enrolled

Overview

The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).

Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT approximately 3l/min via nasal cannula according to a randomized cross-over design. The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air. The effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pulmonary Vascular Disorder Chronic Thromboembolic Pulmonary Hypertension Pulmonary Arterial Hypertension

Interventions

6-minute walk distance (6MWD) test on ambient airOTHER

6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards

6-minute walk distance test with supplemental oxygenOTHER

6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Minimum 18 years of age * Written informed consent * Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH) * Former desaturation under exercise defined as Spo2-decrease \>3% * Treated with a stable drug therapy (with no changes for at least 14 days prior to screening) Exclusion Criteria: * Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (PaO2) \< 6.9 Kilopascal (kPa) * Pregnancy * Unability or contraindications to undergo the investigated intervention * Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc

Locations (1)

University Hospital Zürich

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air

Change in 6MWD in meter between SOT via nasal cannula vs. ambient air

Time frame: after 6 minutes

Secondary Outcomes

SpO2 at rest and peak 6MWD with SOT vs. ambient air

Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with SOT approximately 3l /min vs. ambient air

Time frame: after 6 minutes

Heart rate at rest and peak 6MWD with SOT vs. ambient air

Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air

Time frame: after 6 minutes

Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air

Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with SOT vs. ambient air

Time frame: 6 minutes

Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air

Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWD with SOT vs. ambient air

Time frame: 6 minutes

Blood pressure at rest and peak 6MWD with SOT vs. ambient air

Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air

Time frame: after 6 minutes

Data from ClinicalTrials.gov

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