Acute Exposure of Simulated Hypoxia on ECG and Non-invasive Blood Pressure

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581851
• Other study ID #: 2018-00455_A5
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: January 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.

Description:

Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six Minute Walking test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise. Randomly assigned to the order of testing, the participants will e tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device. During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) = 25 mmHg along with a pulmonary artery wedge pressure (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 partial O2 pressure (PaO2) =7.3 kiloPascal (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, High Altitude Pulmonary Edema (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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Hypoxia
• Pulmonary Hypertension

Intervention

Device:
• Simulated Altitude: (FiO2: 15.1)
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
• Shamed Hypoxia (FiO2: 20.9)
Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.

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	Non-invasive blood pressure (Finapres)	Change in non-invasive bloodpressure (systolic and diastolic) assessed with a finger cuff (Finapres) during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia	1 hour
Secondary	Electrocardiography	Change in cardiac repolarization during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia	1 hour