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

NCT ID: NCT06384534

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-07-01

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).

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ambient air

Patient will perform tests at University Hospital Zurich

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

SOT via basal canula

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.

Group Type: ACTIVE_COMPARATOR

6-minute walk distance test with supplemental oxygen

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Ulrich, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Pulmonology

Locations

University Hospital Zürich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

PVD_6MWD_SOT

Identifier Type: -

Identifier Source: org_study_id