HA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)

Study Purpose

To study the effect of SOT in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics by echocardiography and in relation to blood gases at 2840m with and without SOT.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult patients 18-80 years old of both genders, - Residence > 2500m of altitude.

- diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines.

- Patients stable on therapy.

- New York Heart Association (NYHA) functional class I-III.

- Provided written informed consent to participate in the study.

Exclusion Criteria:

- Age <18 years or >80 years.

- unstable condition.

- Patients who cannot follow the study investigations, patient permanently living < 2500m.

- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day) - Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulseoximetry (SpO2) <80% on ambient air.

- Patients with chronic mountain sickness (Hemoglobin > 19 g/dl in women, >21 g/dl in men) - Patient with a non-corrected ventricular septum defect.

- Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06084559
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Zurich
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Silvia Ulrich, Prof. Dr.Rodrigo Hoyos, Dr.
Principal Investigator Affiliation	University Hospital Zurich, Departement of PulmonologyCarlos Adrade Marin Hospital of Quito, Equador
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Switzerland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Vascular Disorder, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension

Additional Details

Patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA >2500 (PVDHA) will have echocardiografy to assess PAP, cardiac output and other hemodynamics and arterial blood gas to assess SaO2, PaO2 and PaCO2 near their living altitude in Quito at 2840m whilst breathing ambient air or SOT at 10l/min flow via a face mask with reservoir.

Arms & Interventions

Arms

Sham Comparator: Placebo (ambient hypoxic air at 2840m)

Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir

Experimental: SOT (high flow supplemental oxygen therapy)

SOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir

Interventions

Other: - Supplemental oxygen therapy

Mobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied

Other: - Sham Oxygen therapy

Patients will reveice pressurized air via a nasal cannula

Contact a Trial Team

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International Sites

University Hospital Zürich, Zurich, Switzerland

Status

Address

University Hospital Zürich

Zurich, , 8091

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