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

The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects

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

Study Overview

• Status: Completed
• Conditions: High Altitude Pulmonary Hypertension
• Intervention / Treatment: Procedure: High altitude exposure; Procedure: Low altitude exposure

Detailed Description

Patients with pulmonary hypertension will perform a constant work-rate exercise test at low altitude (450m) and at high altitude 2500m in a randomized-cross-over sequence protocol. The constant work-rate exercise test time and other measures will be assessed

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital of Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Constant work-rate at altitude 2500 m above sea level (high altitude); Cycling at high altitude	Procedure: High altitude exposure; Exposure to 2500m of altitude; Procedure: Low altitude exposure; Exposure to 490 m
Active Comparator: Constant work-rate at altitude 470 m above sea level (low altitude); Cycling at low altitude	Procedure: High altitude exposure; Exposure to 2500m of altitude; Procedure: Low altitude exposure; Exposure to 490 m

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Difference in cardiorespiratory measurements: Heart rate, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude	30 hours
Ventilation in liters per minute	Difference in cardiorespiratory measurements: Ventilation assessed in liters per minute, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude	30 hours
Oxygen uptake	Difference in cardiorespiratory measurements: oxygen uptake, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude	30 hours
Oxygen saturation	Difference in cardiorespiratory measurements: Oxygen saturation, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude	30 hours
Partial pressure or oxygen	Difference in partial pressure of oxygen at the beginning and end of a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude	30 hours
Tricuspid pressure gradient	Trans-tricuspid pressure gradient by echocardiography	30 hours
Borg dyspnoea scale	Difference in post-exercise Borg dyspnoea and leg fatigue scale during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude	30 hours
Visual analogue scale	Difference in baseline in symptoms assessed by the Visual Analogue Scale at high altitude vs. low altitude	30 hours
sit-to-stand test frequency	Difference in baseline in sit-to-stand test frequency of standing up from a chair in a minute at high altitude vs. low altitude	30 hours
6 minute walk test	Difference in baseline in 6 minute walk test distance at high altitude vs. low altitude	30 hours

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: OVERALP II C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No