Maximal Exercise Capacity at 2500 m of High Altitude

NCT05264324 | Completed

• 1 other identifier: OVERALP II D
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

High Altitude Pulmonary Hypertension; Maximal Exercise Capacity

Outcome Measures

Primary Outcomes (1)

• Maximal work rate

  Change in maximal work rate in Watt at 2500 vs. 490 m

  30 hours

Secondary Outcomes (17)

• Heart rate

  30 hours

• Ventilation

  30 hours

• Oxygen uptake

  30 hours

• Arterial blood oxygenation saturation

  30 hours

• Blood gases

  30 hours

Study Arms (2)

High altitude 2500 m above sea level (high altitude)

EXPERIMENTAL

Maximum Exercise Capacity in high altitude

Procedure: Maximal Exercise Capacity

Low altitude 470 m above sea level (low altitude)

ACTIVE COMPARATOR

Maximum Exercise Capacity in low altitude

Procedure: Maximal Exercise Capacity

Interventions

Maximal Exercise Capacity PROCEDURE

Maximal Exercise Capacity in incremental ramp exercise tests.

High altitude 2500 m above sea level (high altitude); Low altitude 470 m above sea level (low altitude)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary edema of mountaineers

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be exposed to ambient air at 490m vs. hypoxic air at 2500m in a randomized sequence according to a cross-over design

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: March 3, 2022
• Study Start: October 20, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

CH (1)