Acute Exposure of High Altitude on Cardiac Output

NCT03637218 | Completed

• 1 other identifier: 2018-00455_B8
• 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 High Altitude (Säntis; 2500m above sea level) on non-invasive cardiac output assessments by Finapres® NOVA Technology at rest and under exercise

Conditions

Pulmonary Hypertension

Keywords

High Altitude; non-invasive cardiac output; Finapres

Outcome Measures

Primary Outcomes (1)

• Cardiac Output measured non-invasively

  Change in non-invasive assessed cardiac output measured with a finger cuff (Finapres) during the exposure to High Altitude (2500m) compared to Low Altitude (Zurich; 470m)

  Averaged over two minutes rest and 30 seconds end of exercise (exhaustion)

Study Arms (2)

Order A

EXPERIMENTAL

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

Other: Assessment at Low Altitude (470m above sea level); Other: Exposure to High Altitude (2500m above sea level)

Order B

EXPERIMENTAL

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

Other: Assessment at Low Altitude (470m above sea level); Other: Exposure to High Altitude (2500m above sea level)

Interventions

Assessment at Low Altitude (470m above sea level) OTHER

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

Order A; Order B

Exposure to High Altitude (2500m above sea level) OTHER

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

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: 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Altitude Sickness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders

Study Officials

• Silvia Ulrich, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Including a baseline assessment and assessments at Low altitude and High altitude

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 17, 2018
• Study Start: July 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

CH (1)