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

October 9, 2023 updated by: University of Zurich

Effect of Supplemental Oxygen Therapy (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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Placebo (ambient hypoxic air at 2840m)
Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir
Other: Sham Oxygen therapy
Patients will reveice pressurized air via a nasal cannula
Other Names:
  • Placebo
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
Other: Supplemental oxygen therapy
Mobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pulmonary Artery Pressure with SOT vs. placebo
Time Frame: at 15 min of breathing ambient air or supplemental oxygen
Change in PAP in mmHg assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
at 15 min of breathing ambient air or supplemental oxygen

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Cardiac Output with SOT vs. placebo
Time Frame: at 15 min of breathing ambient air or supplemental oxygen
Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
at 15 min of breathing ambient air or supplemental oxygen
Change in right to left heart diameter ratio with SOT vs. placebo
Time Frame: at 15 min of breathing ambient air or supplemental oxygen
Change in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
at 15 min of breathing ambient air or supplemental oxygen
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo
Time Frame: at 15 min of breathing ambient air or supplemental oxygen
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air (placebo) 10l/min via facial mask
at 15 min of breathing ambient air or supplemental oxygen
Change in right atrial area with SOT vs. placebo
Time Frame: at 15 min of breathing ambient air or supplemental oxygen
Change in right atrial area by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
at 15 min of breathing ambient air or supplemental oxygen
Change in right heart strain with SOT vs. placebo
Time Frame: at 15 min of breathing ambient air or supplemental oxygen
Change in in right heart strain by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
at 15 min of breathing ambient air or supplemental oxygen
Change in ph by arterial blood gases with SOT vs. placebo
Time Frame: at 15 min of breathing ambient air or supplemental oxygen
Changes in ph by arterial blood gases SaO2, PaO2, PaCO2 with SOT compared to ambient air (placebo) 10l/min via facial mask
at 15 min of breathing ambient air or supplemental oxygen
Change in PaO2 by arterial blood gases with SOT vs. placebo
Time Frame: at 15 min of breathing ambient air or supplemental oxygen
Changes in PaO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask
at 15 min of breathing ambient air or supplemental oxygen
Change in PaCO2 by arterial blood gases with SOT vs. placebo
Time Frame: at 15 min of breathing ambient air or supplemental oxygen
Changes in PaCO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask
at 15 min of breathing ambient air or supplemental oxygen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silvia Ulrich, Prof. Dr., University Hospital Zurich, Departement of Pulmonology
  • Principal Investigator: Rodrigo Hoyos, Dr., Carlos Adrade Marin Hospital of Quito, Equador

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PVD_HA_SOT_PAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

Otherwise, we will share anonymized research data after publication on a open access repository according to FAIR principles.

Decision about the best suitable plattform is ongoing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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