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

Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Other: Low altitude: 470m above sea level; Other: Säntis; 2500m above sea Level

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

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Respiratory Clinic, University Hospital of Zurich

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
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Order A; The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level)	Other: Low altitude: 470m above sea level; Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure; Other: Säntis; 2500m above sea Level; Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
EXPERIMENTAL: Order B; The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).	Other: Low altitude: 470m above sea level; Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure; Other: Säntis; 2500m above sea Level; Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrocardiography	Change in cardiac repolarization during the exposure to High Altitude(2500m)compared to Low Altitude	within 5 hours

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (ACTUAL): July 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Electrocardiography; High Altitude; Non-invasive Blood Pressure; Finapres
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 2018-00455_B7

Drug and device information, study documents

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