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NCT06384534 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

Official 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06384534
Other study ID # PVD_6MWD_SOT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date November 2025

Study information
Verified date April 2024
Source University of Zurich
Contact Silvia Ulrich, Prof. Dr.
Phone +41442552220
Email silvia.ulrich@usz.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 28
Est. completion date November 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland University Hospital Zürich Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 after 6 minutes
Secondary 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 after 6 minutes
Secondary 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 after 6 minutes
Secondary Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air Change of Borg dyspnea scale at rest and at peak 6MWD with SOT vs. ambient air 6 minutes
Secondary Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air Change of Borg leg fatigue scale at rest and at peak 6MWD with SOT vs. ambient air 6 minutes
Secondary 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 after 6 minutes
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