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Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension

Status

Completed

Conditions

Pulmonary Hypertension

Treatments

Other: Hypoxia and Hyperoxia

Study type

Observational

Funder types

Other

Identifiers

NCT03195959
KEK-ZH-Nr. 2016-02136

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

44 participants in 2 patient groups

PH-Patients
Description:
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.
Treatment:
Other: Hypoxia and Hyperoxia
Control group
Description:
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)).
Treatment:
Other: Hypoxia and Hyperoxia

Trial contacts and locations

1

There are currently no registered sites for this trial.

Timeline

Last updated: Nov 02, 2022

Start date

Jun 22, 2017 • 7 years ago

End date

May 01, 2022 • 3 years ago

Today

May 07, 2025

Sponsor of this trial

Data sourced from clinicaltrials.gov