Highlanders With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Arterial Pressure (PAP) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)

NCT ID: NCT06489756

Last Updated: 2025-12-04

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-12-31

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 pulmonary arterial pressure (PAP) assessed at 3200 m.

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 have echocardiografy to assess PAP near their living altitude in Aksay at 3200 m with and without 10L/min supplemental oxygen therapy (SOT) via face mask.

Conditions

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High Altitude Pulmonary Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Each highlander with HAPH will perform a echocardiography 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 echocardiography on ambient air at 3200m

Group Type ACTIVE_COMPARATOR

Echocardiography

Intervention Type OTHER

Echocardiography will be performed according to clinical standards

10 L/min SOT through face mask

Supplemental oxygen therapy (SOT) at 10 L/min will be provided via face mask from oxygen concentrators

Group Type EXPERIMENTAL

Echocardiography

Intervention Type OTHER

Echocardiography will be performed according to clinical standards

Interventions

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Echocardiography

Echocardiography 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

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Talant MA Sooronbaev, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Silvia Ulrich, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Pulmonology

Locations

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Aksay Medical Center

Aksay Plateau, Naryn, Kyrgyzstan, , Kyrgyzstan

Site Status

Countries

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Kyrgyzstan

Other Identifiers

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HAPH_SOT_PAP

Identifier Type: -

Identifier Source: org_study_id

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