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Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03195959
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Pulmonary Hypertension Other: Hypoxia and Hyperoxia

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Effect of Normobaric Hypoxia and Hyperoxia on Pulmonary Hemodynamics in Patients With Pulmonary Hypertension
Actual Study Start Date : June 22, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017


Group/Cohort Intervention/treatment
PH-Patients
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.
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.

Control group
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)).
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.




Primary Outcome Measures :
  1. Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. change of mean pulmonary artery pressure under hyperoxia in comparison to normoxia and hyperoxia [ Time Frame: Day 1 ]
  2. change of the cardiac output under hyperoxia in comparison to normoxia and hyperoxia [ Time Frame: Day 1 ]
  3. change of the partial pressure of carbon dioxide under hyperoxia in comparison to normoxia and hyperoxia [ Time Frame: Day 1 ]
  4. change of the partial pressure of oxygen under hyperoxia in comparison to normoxia and hyperoxia [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195959


Contacts
Contact: Silvia Ulrich Somaini, Prof. Dr. 0041442552220 silvia.ulrich@usz.ch
Contact: Alexandra Groth 0041442552220 alexandra.groth@usz.ch

Locations
Switzerland
UniversityHospital Zurich, Department of Pulmonology Recruiting
Zürich, Switzerland, 8091
Contact: Silvia Ulrich Somaini, Prof. Dr.    0041442552220    silvia.ulrich@usz.ch   
Contact: Alexandra Groth    0041442552220    alexandra.groth@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Silvia Ulrich Somaini, Prof. Dr. UniversityHospital Zurich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03195959     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2016-02136
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
Pulmonary arterial hypertension
Chronic thromboembolic pulmonary hypertension
Hypoxia
Hyperoxia

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Hypoxia
Hyperoxia
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms