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Acute Exposure of Simulated Hypoxia on Blood and Tissue Oxygenation (aBGA, NIRS) | Clinical Trials | Clareo Health

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Acute Exposure of Simulated Hypoxia on Blood and Tissue Oxygenation (aBGA, NIRS)

Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise

NCT03637114•University of Zurich

View on ClinicalTrials.gov

Summary

Randomized crossover trial in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on blood and tissue oxygenation (ABGA, near infrared spectroscopy)

Detailed Description

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas analysis. Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC altitrainer") and shamed altitude with the same device. At rest and under exercise data from ABGA and near infrared spectroscopy will be compared under simulated altitude and shamed altitude.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Informed consent
•PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis
•PH class 1 (PAH) or 4 (CTEPH)
•Stable condition, on the same medication for \> 4 weeks
•Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria

•Resting partial Oxygen pressure (PaO2) ≤7.3 kilopascal (kPA) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
•Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
•Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
•Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
•Residence \> 1000m above sea level
•Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability
•Women who are pregnant or breast feeding

Locations (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, Switzerland

Key Dates

Start Date

August 1, 2018

Primary Completion Date

April 1, 2019

Completion Date

April 1, 2019

Last Updated

January 7, 2020

Enrollment

ACTUAL participants

Conditions

Pulmonary Hypertension

Interventions

Simulated Altitude (FiO2: 15.1%)

DEVICE

Shamed Hypoxia (FiO2: 20.9)

DEVICE

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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RECRUITINGPHASE1

Preliminary Human Trials of F230 Tablets

NCT06899815

Pulmonary Hypertension

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RECRUITINGPHASE2/PHASE3

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Acute Exposure of Simulated Hypoxia on Blood and Tissue Oxygenation (aBGA, NIRS)

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Preliminary Human Trials of F230 Tablets

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

Prospective Evaluation of AI-ECG for SHD Detection

Pulmonary Hypertension in Left Heart Disease

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH