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OpenTrials
Completed

NCT Number: NCT03195959

Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hyperoxia Hypertension Hypertension, Pulmonary Hypoxia Lung Diseases Pathological Conditions, Signs and Symptoms Pulmonary Arterial Hypertension Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UniversityHospital Zurich, Department of Pulmonology

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxia and Hyperoxia

Other

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 outcomes

  1. Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia

    Time frame: Day 1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2017
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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