Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Effect of Normobaric Hypoxia and Hyperoxia on Pulmonary Hemodynamics in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195959
• Other study ID #: KEK-ZH-Nr. 2016-02136
• Status: Completed
• Start date: June 22, 2017
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pulmonary Hypertension (PH) is a severe disease with a bad prognosis. However, thanks to extensive research in this field, there are more and better treatment options that allow patients to participate in recreational activities at moderate altitude or bring up the question of air-travel.

Still very few is known about the effects hypoxic conditions have on PH patients. The aim of this study is to investigate the effects of hypoxia in comparison to normoxia and hyperoxia on pulmonary hemodynamics in patients with pulmonary hypertension during routine right heart catheterisation. We aim to get insight into the pathophysiology of pulmonary hemodynamics under hypoxic conditions in comparison to normoxia and hyperoxia in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension compared with control patients, that are scheduled for right heart catheterisation due to dyspnea but have no PH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinically indicated right heart catheterisation

• diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension or control without pulmonary hypertension

Exclusion Criteria:

• hemodynamically unstable

• partial pressure of Oxygen < 7.3kPa

• no informed consent

• pulmonary hypertension due to left heart disease, chronic lung disease or miscellaneous (Groups II, III and V) according to Galié ERJ 2015

Related Conditions & MeSH terms

• Hyperoxia
• Hypertension
• Hypertension, Pulmonary
• Hypoxia
• Pulmonary Hypertension

Intervention

Other:
• Hypoxia and Hyperoxia
10 minutes of breathing a gas mixture with FiO2 0.16 via a tight fitting mask. After 10 minutes of breathing ambient air (normoxia), patients were exposed to hyperoxia (FiO2 1.0) for 10 minutes.

Locations

Country	Name	City	State
Switzerland	UniversityHospital Zurich, Department of Pulmonology	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia		Day 1
Secondary	change of mean pulmonary artery pressure under hyperoxia in comparison to normoxia and hyperoxia		Day 1
Secondary	change of the cardiac output under hyperoxia in comparison to normoxia and hyperoxia		Day 1
Secondary	change of the partial pressure of carbon dioxide under hyperoxia in comparison to normoxia and hyperoxia		Day 1
Secondary	change of the partial pressure of oxygen under hyperoxia in comparison to normoxia and hyperoxia		Day 1