Exercise Endurance Time on the 2nd Day at 2500 m High Altitude

NCT05131737 | Completed

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

Brief Summary

The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension

Conditions

High Altitude Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• cycle constant work-rate exercise test

  Difference in cycle constant work-rate exercise test (CWRET) time at 2500 vs. 490 m (Time Frame 24 to 30 hours)

  30 hours

Secondary Outcomes (10)

• Heart rate

  30 hours

• Ventilation in liters per minute

  30 hours

• Oxygen uptake

  30 hours

• Oxygen saturation

  30 hours

• Partial pressure or oxygen

  30 hours

Study Arms (2)

Constant work-rate at altitude 2500 m above sea level (high altitude)

EXPERIMENTAL

Cycling at high altitude

Procedure: High altitude exposure; Procedure: Low altitude exposure

Constant work-rate at altitude 470 m above sea level (low altitude)

ACTIVE COMPARATOR

Cycling at low altitude

Procedure: High altitude exposure; Procedure: Low altitude exposure

Interventions

High altitude exposure PROCEDURE

Exposure to 2500m of altitude

Constant work-rate at altitude 2500 m above sea level (high altitude); Constant work-rate at altitude 470 m above sea level (low altitude)

Low altitude exposure PROCEDURE

Exposure to 490 m

Constant work-rate at altitude 2500 m above sea level (high altitude); Constant work-rate at 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
• 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)

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: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 23, 2021
• Study Start: October 18, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

CH (1)