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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-07-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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High Altitude Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each highlander with HAPH will perform a 6 MWT with and without SOT according to a cross-over design.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ambient air

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

Group Type ACTIVE_COMPARATOR

6-minute walk test (6MWT)

Intervention Type OTHER

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

SOT via nasal canula

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

Group Type EXPERIMENTAL

6-minute walk test (6MWT)

Intervention Type OTHER

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

Interventions

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6-minute walk test (6MWT)

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No