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

University of Zurich24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

High Altitude Pulmonary Hypertension

Interventions

6-minute walk test (6MWT)OTHER

6-minute walk test (6MWT) will be performed according to clinical standards

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Aksay Medical Center

Aksay Plateau, Naryn Region, Kyrgyzstan

Outcomes

Primary Outcomes

6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m

Change in 6MWD in meters between SOT vs. ambient air at 3200 m

Time frame: after 6 minute

Secondary Outcomes

SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m

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

Time frame: after 6 minute

Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m

Change of the heart rate at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m

Time frame: after 6 minute

Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m

Change of the blood pressure at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m

Time frame: after 6 minute

Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m

Change of the Borg CR10 dyspnea scale at end of the 6MWT with SOT vs. ambient air at 3200 m

Time frame: after 6 minute

Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m

Change of the Borg CR10 leg fatigue scale at end of the 6MWT with SOT vs. ambient air at 3200 m

Time frame: after 6 minute

Data from ClinicalTrials.gov

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