Highlanders With High Altitude Pulmonary Hypertension (HAPH), 6 Minute Walk Distance (6MWD) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)

University of Zurich (UZH)

Status: Completed

Conditions: High Altitude Pulmonary Hypertension

Treatments: Other: 6-minute walk test (6MWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06489743

HAPH_SOT_6MWT

Details and patient eligibility

About

The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live >2500m on 6-minute walk distance (6MWD) assessed at 3200m.

Full description

Highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA (Tricuspid Regurgitation Pressure Gradient) >30 mmHg will be recruited for this project. Highlanders permanently living at HA >2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m with and without portable pulsed supplemental oxygen therapy (SOT) via nasal cannula according to a randomized cross-over design.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Permanently living >2500 m
• HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
• Written informed consent

Exclusion criteria

• Highlanders who cannot follow the study investigations,
• Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, heavy smoking >20 cigarettes/day or >20 pack-years.
• Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
• Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Ambient air

Active Comparator group

Description:

Highlanders with HAPH will perform the 6 MWT on ambient air at 3200 m

Treatment:

Other: 6-minute walk test (6MWT)

SOT via nasal canula

Experimental group

Description:

Portable pulsed supplemental oxygen therapy (SOT) will be provided via a nasal cannula from a regular portable oxygen concentrator carried on the back according to standard care

Treatment:

Other: 6-minute walk test (6MWT)