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Completed

NCT Number: NCT06384534

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

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).

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Key information

Conditions

Pulmonary Vascular Disorder Cardiovascular Diseases Chronic Thromboembolic Pulmonary Hypertension Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

6-minute walk distance test with supplemental oxygen

Other

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

Primary outcomes

  1. 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air

    Time frame: after 6 minutes

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

Secondary outcomes

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

    Time frame: after 6 minutes

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

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

    Time frame: after 6 minutes

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

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

    Time frame: 6 minutes

    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

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

    Time frame: 6 minutes

    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

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

    Time frame: after 6 minutes

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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Oxygen Therapy - a Non-inferiority Trial in Patients With Exercise Induced Desaturation Due to Pulmonary Vascular Disease (PVD)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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