Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m

NCT ID: NCT05112172

Last Updated: 2022-05-11

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

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2022-04-15

Brief Summary

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To study whether oxygen therapy titrated to maintain oxygenation (SpO2) \> 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.

Detailed Description

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Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.

Conditions

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High Altitude Pulmonary Hypertension Oxygen Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxygen Therapy

Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude

Group Type EXPERIMENTAL

Oxygen Therapy

Intervention Type OTHER

Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude

Interventions

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Oxygen Therapy

Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed consent as documented by signature
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria

* resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Minimum Eligible Age

18 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

Locations

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Respiratory Clinic, University Hospital of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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OVERALP II B

Identifier Type: -

Identifier Source: org_study_id

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