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

NCT06384534 | Completed

• 1 other identifier: PVD_6MWD_SOT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Arterial Hypertension; Pulmonary Vascular Disorder

Keywords

Pulmonary Hypertension; Supplemental Oxygen Therapy; Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Vascular Disease; 6 Minute Walking Distance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  after 6 minutes

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

  after 6 minutes

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

  6 minutes

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

  6 minutes

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

  after 6 minutes

Study Arms (2)

Ambient air

EXPERIMENTAL

Patient will perform tests at University Hospital Zurich

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

SOT via basal canula

ACTIVE COMPARATOR

Supplemental Oxygen Therapy (SOT) at approximately 3l/min will be provided via nasal canula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich.

Other: 6-minute walk distance test with supplemental oxygen

Interventions

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

Ambient air

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)

SOT via basal canula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Silvia Ulrich, Prof. Dr.

  University Hospital Zurich, Department of Pulmonology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant is its own control

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 25, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)