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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Vascular Disorder Pulmonary Artery Hypertension Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant works as its own perfect control

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Sham SOT (placebo, ambient hypoxic air at 2840m) versus high-flow oxygen 10l/min both via a facial mask with reservoir will be applied

Study Groups

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Placebo (ambient hypoxic air at 2840m)

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

Group Type SHAM_COMPARATOR

Sham Oxygen therapy

Intervention Type OTHER

Patients will reveice pressurized air via a nasal cannula

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

Group Type EXPERIMENTAL

Supplemental oxygen therapy

Intervention Type OTHER

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

Interventions

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Supplemental oxygen therapy

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

Intervention Type OTHER

Sham Oxygen therapy

Patients will reveice pressurized air via a nasal cannula

Intervention Type OTHER

Other Intervention Names

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Placebo

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No