Acute Exposure of Simulated Hypoxia on Heart Rate and Ventilation During Exercise

NCT03592979 | Completed

• 1 other identifier: 2018-00455_A7
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 heart rate and Ventilation changes under exercise.

Conditions

Pulmonary Hypertension

Keywords

Simulated altitude; exercise; ventilation; heart rate

Outcome Measures

Primary Outcomes (1)

• heart rate under exercise

  Change in heart rate under exercise during the exposure to simulated altitude (FiO2: 15,1%) and normoxia.

  1 hour

Secondary Outcomes (1)

• Ventilation under exercise

  1 hour

Study Arms (2)

Order A

EXPERIMENTAL

The participants will be consecutively exposed to shamed hypoxia (FiO2: 20.9%) equivalent to sea level and to simulated altitude (FiO2: 15.1%) equivalent to 2500m above sea level administered by an altitude simulator ("Altitrainer, SMTEC") with a facemask.

Device: Simulated Altitude: (FiO2: 15.1); Device: Shamed Hypoxia (FiO2: 20.9)

Order B

EXPERIMENTAL

The participants will be consecutively exposed to hypoxia (FiO2: 15,1%) equivalent to 2500m above sea level and to shamed hypoxia (FiO2: 20.9%) equivalent to sea level administered by an altitude simulated ("Altitrainer, SMTEC") with a facemask.

Device: Simulated Altitude: (FiO2: 15.1); Device: Shamed Hypoxia (FiO2: 20.9)

Interventions

Simulated Altitude: (FiO2: 15.1) DEVICE

Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.

Order A; Order B

Shamed Hypoxia (FiO2: 20.9) DEVICE

Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.

Order A; Order B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Resting partial oxygen 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Motor Activity; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia Ulrich, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The allocated gas mixture will not be disclosed to the patient since he will breath trough a facemask during both interventions.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Including a baseline assessment and assessments under simulated altitude and normoxia

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: July 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

CH (1)