Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Other: Hypoxia and Hyperoxia

• Registration Number: NCT03195959
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study Start: 2017-06-22
• Study First Posted: 2017-06-22
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Hypoxia and Hyperoxia	Patients with clinically indicated right heart catheterisation (because of dyspnea or other signs of PH), but had no PH (no elevated mean pulmonary artery pressure (mPAP \<20mmHg)).
PH-Patients	Hypoxia and Hyperoxia	Patients with mean pulmonary artery pressure \>25mmHg and a pulmonary arterial wedge pressure \<15mmHg during right heart catheterisation, which are diagnosed as having pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension.

Primary Outcome Measures

Name	Time	Method
Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia	Day 1

Secondary Outcome Measures

Name	Time	Method
change of the partial pressure of oxygen under hyperoxia in comparison to normoxia and hyperoxia	Day 1
change of the partial pressure of carbon dioxide under hyperoxia in comparison to normoxia and hyperoxia	Day 1
change of mean pulmonary artery pressure under hyperoxia in comparison to normoxia and hyperoxia	Day 1
change of the cardiac output under hyperoxia in comparison to normoxia and hyperoxia	Day 1

Trial Locations

Locations (1)

UniversityHospital Zurich, Department of Pulmonology; 🇨🇭 Zürich, Switzerland