Maximal Exercise Capacity at 2500 m of High Altitude

NCT ID: NCT05264324

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2022-04-15

Brief Summary

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The impact of hypoxia on maximal work rate during incremental ramp exercise within 3-6 hours after arriving at 2500m of high altitude in patients with precapillary pulmonary hypertension

Detailed Description

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Conditions

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High Altitude Pulmonary Hypertension Maximal Exercise Capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will be exposed to ambient air at 490m vs. hypoxic air at 2500m in a randomized sequence according to a cross-over design
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High altitude 2500 m above sea level (high altitude)

Maximum Exercise Capacity in high altitude

Group Type EXPERIMENTAL

Maximal Exercise Capacity

Intervention Type PROCEDURE

Maximal Exercise Capacity in incremental ramp exercise tests.

Low altitude 470 m above sea level (low altitude)

Maximum Exercise Capacity in low altitude

Group Type ACTIVE_COMPARATOR

Maximal Exercise Capacity

Intervention Type PROCEDURE

Maximal Exercise Capacity in incremental ramp exercise tests.

Interventions

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Maximal Exercise Capacity

Maximal Exercise Capacity in incremental ramp exercise tests.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Informed consent as documented by signature (Appendix Informed Consent Form)
* 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 D

Identifier Type: -

Identifier Source: org_study_id

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