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

High Altitude Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05131737
• Other study ID #: OVERALP II C
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: May 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• High Altitude Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Procedure:
• High altitude exposure
Exposure to 2500m of altitude
• Low altitude exposure
Exposure to 490 m

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Tricuspid pressure gradient	Trans-tricuspid pressure gradient by echocardiography	30 hours
Secondary	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
Secondary	Visual analogue scale	Difference in baseline in symptoms assessed by the Visual Analogue Scale at high altitude vs. low altitude	30 hours
Secondary	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
Secondary	6 minute walk test	Difference in baseline in 6 minute walk test distance at high altitude vs. low altitude	30 hours