Clinical trial NCT06489743: Highlanders With High Altitude Pulmonary Hypertension (HAPH), 6 Minute Walk Distance (6MWD) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)
Official title: Effect of Supplemental Oxygen Therapy (SOT) on 6-minute Walk Distance (6MWD) in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High Altitude Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Hypoxia
High Altitude
Supplemental Oxygen Therapy
6-Minute Walk Test
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each highlander with HAPH will perform a 6 MWT with and without SOT according to a cross-over design.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m
timeFrame: after 6 minute
Secondary outcomes:
measure: SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m
timeFrame: after 6 minute
measure: Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m
timeFrame: after 6 minute
measure: Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m
timeFrame: after 6 minute
measure: Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m
timeFrame: after 6 minute
measure: Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m
timeFrame: after 6 minute
Other outcomes:
Locations:
city: Aksay Plateau
country: Kyrgyzstan
facility: Aksay Medical Center
state: Naryn
Study officials:
affiliation: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
name: Talant MA Sooronbaev, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: