Comparing exercise performance with and without oxygen therapy in pulmonary vascular disease
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)
This study is testing if using supplemental oxygen during exercise can help people with pulmonary vascular diseases, like pulmonary arterial hypertension, walk further compared to exercising without oxygen.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT06384534 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of supplemental oxygen therapy (SOT) on exercise performance in Swiss residents diagnosed with pulmonary vascular diseases, specifically pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Participants will undergo a 6-minute walk distance (6MWD) test both with and without SOT in a randomized cross-over design. The goal is to determine if the 6MWD with SOT is non-inferior to the 6MWD performed under ambient air conditions. The study aims to provide insights into the effectiveness of SOT for improving exercise capacity in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diagnosed pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension who have experienced desaturation during exercise.
Not a fit: Patients with severe hypoxemia requiring supplemental oxygen therapy or those unable to participate due to psychological or language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize oxygen therapy for patients with pulmonary vascular diseases, potentially improving their exercise capacity and quality of life.
How similar studies have performed: Other studies have explored the effects of supplemental oxygen in similar patient populations, indicating potential benefits, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zurich
- University Hospital Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Silvia Ulrich, Prof. Dr. — University Hospital Zurich, Department of Pulmonology
- Study coordinator: Silvia Ulrich, Prof. Dr.
- Email: silvia.ulrich@usz.ch
- Phone: +41442552220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.