Clinical trial NCT03195959: Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension
Official title: Effect of Normobaric Hypoxia and Hyperoxia on Pulmonary Hemodynamics in Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary arterial hypertension
Chronic thromboembolic pulmonary hypertension
Hypoxia
Hyperoxia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that come to our PH referral center for evaluation of PH and undergo a clinically indicated right heart catheterisation.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia
timeFrame: Day 1
Secondary outcomes:
measure: change of mean pulmonary artery pressure under hyperoxia in comparison to normoxia and hyperoxia
timeFrame: Day 1
measure: change of the cardiac output under hyperoxia in comparison to normoxia and hyperoxia
timeFrame: Day 1
measure: change of the partial pressure of carbon dioxide under hyperoxia in comparison to normoxia and hyperoxia
timeFrame: Day 1
measure: change of the partial pressure of oxygen under hyperoxia in comparison to normoxia and hyperoxia
timeFrame: Day 1
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: UniversityHospital Zurich, Department of Pulmonology
Study officials:
affiliation: UniversityHospital Zurich
name: Silvia Ulrich Somaini, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: