Maximal Exercise Capacity at 2500 m of 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: NCT05264324
• Other study ID #: OVERALP II D
• Status: Completed
• Phase: N/A
• Start date: October 20, 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 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

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 (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)

Related Conditions & MeSH terms

• High Altitude Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Procedure:
• Maximal Exercise Capacity
Maximal Exercise Capacity in incremental ramp exercise tests.

Locations

Country	Name	City	State
Switzerland	Respiratory Clinic, 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	Maximal work rate	Change in maximal work rate in Watt at 2500 vs. 490 m	30 hours
Secondary	Heart rate	Change in cardiorespiratory measurements: heart rate during a cycle incremental ramp exercise test at high altitude vs. low altitude	30 hours
Secondary	Ventilation	Change in cardiorespiratory measurements: ventilation during a cycle incremental ramp exercise test at high altitude vs. low altitude	30 hours
Secondary	Oxygen uptake	Change in cardiorespiratory measurements: Oxygen uptake, SpO2, blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude	30 hours
Secondary	Arterial blood oxygenation saturation	Change in cardiorespiratory measurements: Oxygenation (SpO2) during a cycle incremental ramp exercise test at high altitude vs. low altitude	30 hours
Secondary	Blood gases	Change in blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude	30 hours
Secondary	Hemodynamics	Change in hemodynamics assessed by echocardiography	30 hours
Secondary	Borg dyspnoea and leg fatigue scale	Change in post-exercise Borg dyspnoea and leg fatigue scale during a cycle incremental ramp exercise test at high altitude vs. low altitude	30 hours
Secondary	Visual Analogue Scale for dyspnea	Change Visual Analogue Scale at high altitude vs. low altitude according to a 10cm scale from left to right, where the subject has to mark dyspnea with higher values in cm meaning worse dyspnea	30 hours
Secondary	Electro cardiography	Prevalence of abnormal resting electro cardiography (ECG) at high altitude vs. low altitude	30 hours
Secondary	Electro cardiography :ST-segment changes	Difference in ST-segment changes during cycle incremental ramp and constant work-rate exercise tests at high altitude vs. low altitude	30 hours
Secondary	Electro cardiography: ST-segment changes under oxygen	7Difference in ST-segment changes during cycle exercise tests without and with oxygen at high altitude	30 hours
Secondary	Electro cardiography: Clinically relevant ischemia	Incidence of clinically relevant ischemia (>1mm ST-segment depression) during cycle exercise tests at high altitude vs. low altitude	30 hour
Secondary	Electro cardiography: QT-Interval	Change of corrected QT-Interval, during cycle exercise tests at high vs. low altitude	30 hours
Secondary	Electro cardiography: QT-Interval	Change of corrected QRS duration, during cycle exercise tests at high vs. low altitude	30 hours
Secondary	Electro cardiography: PQ-Interval	Change of corrected PQ-Interval, during cycle exercise tests at high vs. low altitude	30 hours
Secondary	Rate pressure product	Change of corrected Rate pressure product, during cycle exercise tests at high vs. low altitude	30 hours
Secondary	Electro cardiography: Cardiac arrhythmia	Incidence of cardiac arrhythmia during cycle exercise tests at high altitude vs. low altitude	30 hours