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

Primary Purpose

Pulmonary Hypertension

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Low altitude: 470m above sea level

Säntis; 2500m above sea Level

About this trial

This is an interventional prevention trial for Pulmonary Hypertension focused on measuring High Altitude, Exercise, Electrocardiography, Non-invasive Blood Pressure, Finapres

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Respiratory Clinic, University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Order A

Order B

Arm Description

The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Electrocardiography

Change in cardiac repolarization during the exposure to High Altitude(2500m)compared to Low Altitude

Full Information

NCT ID

NCT03593083

First Posted

July 9, 2018

Last Updated

January 6, 2020

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT03593083

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

January 1, 2019 (Actual)

Study Completion Date

January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension

Keywords

High Altitude, Exercise, Electrocardiography, Non-invasive Blood Pressure, Finapres

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Including a baseline assessment and assessments at Low alitude and High altitude

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Order A

Arm Type

Experimental

Arm Description

The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level)

Arm Title

Order B

Arm Type

Experimental

Arm Description

The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).

Intervention Type

Other

Intervention Name(s)

Low altitude: 470m above sea level

Intervention Description

Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

Intervention Type

Other

Intervention Name(s)

Säntis; 2500m above sea Level

Intervention Description

Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

Primary Outcome Measure Information:

Title

Non-invasive blood pressure (Finapres)

Description

Change in non-invasive bloodpressure assessed with a finger cuff (Finapres) during the exposure High Altitude (2500m) compared to Low Altitude

Time Frame

within 5 hours

Secondary Outcome Measure Information:

Title

Electrocardiography

Description

Change in cardiac repolarization during the exposure to High Altitude(2500m)compared to Low Altitude

Time Frame

within 5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Silvia Ulrich, Prof.

Organizational Affiliation

University of Zurich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Respiratory Clinic, University Hospital of Zurich

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

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

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