Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension

NCT03195959 | Completed

• 1 other identifier: KEK-ZH-Nr. 2016-02136
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary arterial hypertension; Chronic thromboembolic pulmonary hypertension; Hypoxia; Hyperoxia

Outcome Measures

Primary Outcomes (1)

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

  Day 1

Secondary Outcomes (4)

• 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

• change of the partial pressure of carbon dioxide under hyperoxia in comparison to normoxia and hyperoxia

  Day 1

• change of the partial pressure of oxygen under hyperoxia in comparison to normoxia and hyperoxia

  Day 1

Study Arms (2)

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

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

Interventions

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.

Control group; PH-Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• clinically indicated right heart catheterisation
• diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension or control without pulmonary hypertension

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

UniversityHospital Zurich, Department of Pulmonology

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypoxia; Hyperoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia Ulrich Somaini, Prof. Dr.

  UniversityHospital Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: June 22, 2017
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)