Acute Excposure of High Altitude on ECG and Non-invasive Blood Pressure.

Not Applicable

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Other: Säntis; 2500m above sea Level

• Registration Number: NCT03593083
• Lead Sponsor: University of Zurich

Brief Summary

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response of High Altitude (Säntis, 2500m above sea level) on ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.

Detailed Description

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

During the exposure High Alitude (2500m above sea level) and low alitude (Zurich) up to 5 hours, the participants' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-19
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Informed consent
• PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
• PH class 1 (PAH) or 4 (CTEPH)
• Stable condition, on the same medication for > 4 weeks
• Patient live permanently at an altitude < 1000m asl.

Exclusion Criteria

• Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
• Severe daytime hypercapnia (pCO2 > 6.5 kPa)
• Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
• Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
• Residence > 1000m above sea level
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
• Women who are pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Order A	Säntis; 2500m above sea Level	The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level)
Order B	Säntis; 2500m above sea Level	The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).

Primary Outcome Measures

Name	Time	Method
Non-invasive blood pressure (Finapres)	within 5 hours	Change in non-invasive bloodpressure assessed with a finger cuff (Finapres) during the exposure High Altitude (2500m) compared to Low Altitude

Secondary Outcome Measures

Name	Time	Method
Electrocardiography	within 5 hours	Change in cardiac repolarization during the exposure to High Altitude(2500m)compared to Low Altitude

Trial Locations

Locations (1)

Respiratory Clinic, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland