Back to resultsHigh Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT)
Primary Purpose
Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
6-minute walk distance (6MWD) test
6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)
Sponsored by
About this trial
This is an interventional other trial for Pulmonary Vascular Disease focused on measuring Pulmonary Hypertension, Hypoxia, Supplemental Oxygen Therapy, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude, Pulmonary vascular disease
Eligibility Criteria
IInclusion 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)
Sites / Locations
- University Hospital Zürich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ambient air
SOT via nasal canula
Arm Description
Patient will perform tests on ambient air at 2840 m
Supplemental oxygen therapy (SOT) at 3l/min will be provided via a nasal cannula from a small oxygen bottle carried on the back according to standard care
Outcomes
Primary Outcome Measures
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m
Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m
Secondary Outcome Measures
SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m
Change of the arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m
Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m
Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m
Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06003244
Brief Title
High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT)
Official Title
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 6-minute Walk Distance (6MWD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to study the effect of SOT in participants with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on 6-minute walk distance (6MWD) assessed at 2840m.
Detailed Description
Participants 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 6-minute walk distance near their living altitude in Quito at 2840m with and without SOT at 3l/min via nasal cannula according to a randomized cross-over design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Keywords
Pulmonary Hypertension, Hypoxia, Supplemental Oxygen Therapy, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude, Pulmonary vascular disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant works as its own perfect control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ambient air
Arm Type
Active Comparator
Arm Description
Patient will perform tests on ambient air at 2840 m
Arm Title
SOT via nasal canula
Arm Type
Experimental
Arm Description
Supplemental oxygen therapy (SOT) at 3l/min will be provided via a nasal cannula from a small oxygen bottle carried on the back according to standard care
Intervention Type
Other
Intervention Name(s)
6-minute walk distance (6MWD) test
Intervention Description
6-minute walk distance (6MWD) test will be performed according to clinical standards
Intervention Type
Other
Intervention Name(s)
6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)
Intervention Description
6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (3l/min, nasal)
Primary Outcome Measure Information:
Title
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m
Description
Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m
Time Frame
after 6 minute
Secondary Outcome Measure Information:
Title
SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m
Description
Change of the arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Time Frame
6 minutes
Title
Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m
Description
Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Time Frame
6 minutes
Title
Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m
Description
Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Time Frame
6 minutes
Title
Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m
Description
Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
IInclusion 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, Prof. Dr.
Organizational Affiliation
University Hospital Zurich, Departement of Pulmonology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodrigo Hoyos, Dr.
Organizational Affiliation
Carlos Adrade Marin Hospital of Quito, Equador
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Learn more about this trial
High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT)
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