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

Not Applicable

Not yet recruiting

• Conditions: High Altitude Pulmonary Hypertension
• Interventions: Other: 6-minute walk test (6MWT)

• Registration Number: NCT06489743
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study Start: 2024-07-01
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SOT via nasal canula	6-minute walk test (6MWT)	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
Ambient air	6-minute walk test (6MWT)	Highlanders with HAPH will perform the 6 MWT on ambient air at 3200 m

Primary Outcome Measures

Name	Time	Method
6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m	after 6 minute	Change in 6MWD in meters between SOT vs. ambient air at 3200 m

Secondary Outcome Measures

Name	Time	Method
Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m	after 6 minute	Change of the Borg CR10 leg fatigue scale at end of the 6MWT with SOT vs. ambient air at 3200 m
Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m	after 6 minute	Change of the blood pressure at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m
Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m	after 6 minute	Change of the Borg CR10 dyspnea scale at end of the 6MWT with SOT vs. ambient air at 3200 m
SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m	after 6 minute	Change of the arterial oxygen saturation by pulse oximetry (SpO2) at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m
Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m	after 6 minute	Change of the heart rate at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m

Trial Locations

Locations (1)

Aksay Medical Center; 🇰🇬 Aksay Plateau, Naryn, Kyrgyzstan