Back to resultsHigh Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
Primary Purpose
Pulmonary Vascular Disease, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Relocation from HA to LA
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Vascular Disease focused on measuring pulmonary hypertension, Pulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension, high altitude, hypoxia, pulmonary artery pressure, arterial blood gases
Eligibility Criteria
Inclusion Criteria: Adult patients 18-90 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 pulse-oximetry (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
- Respiratory Clinic, University Hospital of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Investigations at High altitude (HA, 2840m)
Investigations at Low altitude (LA, sea level)
Arm Description
PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m
PAP and other hemodynamics assessed by echocardiography and blood gases after the first and second night at LA (sea level)
Outcomes
Primary Outcome Measures
Pulmonary artery Pressure (PAP) in the morning of second day at sea level (LA)
Change in PAP in mmHg assessed by echocardiography between LA (sea level) vs High altitude (HA)
Secondary Outcome Measures
Cardiac output in the morning of the second day at sea level
Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840 m)
Cardiac output in the morning of the third day at sea level
Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840m)
Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level
Tricuspid pressure gradient assessed by echocardiography between LA (sea level) vs HA (2840m)
Tricuspid pressure gradient by echocardiography in the morning of the third day at sea level
Tricuspid pressure gradient assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)
Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level
Tricupsid annular plane systolic excursion assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)
Tricupsid annular plane systolic excursion by echocardiography in the morning of the third day at sea level
Tricupsid annular plane systolic excursion by echocardiography assessed by between LA (sea level) vs HA (2840m)
ph by arterial blood gases in the morning of the second day at sea level
Change in ph by arterial blood gases assessed between LA (sea level) vs HA (2840m)
partial pressure of oxygen (PaO2) by arterial blood gases in the morning of the second day at sea level
Change in partial pressure of oxygen (PaO2) assessed by arterial blood gases between LA (sea level) vs HA (2840m)
partial pressure of carbon dioxide (PaCO2) by arterial blood gases in the morning of the second day at sea level
Change in partial pressure of carbon dioxide (PaCO2) assessed by arterial blood gases partial pressure of carbon dioxide (PaCO2) between LA (sea level) vs HA (2840m)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06092424
Brief Title
High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
Official Title
Comparative Study of Pulmonary Artery Pressure (PAP) and Other Hemodynamics Assessed by Echocardiography in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level
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, 2024 (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
To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) 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.
Detailed Description
This research in 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 (PVD_HA) will have PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Vascular Disease, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Keywords
pulmonary hypertension, Pulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension, high altitude, hypoxia, pulmonary artery pressure, arterial blood gases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients will be investigated at high altitude (HA, 2840m) and low altitude (LA, sea level)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigations at High altitude (HA, 2840m)
Arm Type
Active Comparator
Arm Description
PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m
Arm Title
Investigations at Low altitude (LA, sea level)
Arm Type
Experimental
Arm Description
PAP and other hemodynamics assessed by echocardiography and blood gases after the first and second night at LA (sea level)
Intervention Type
Behavioral
Intervention Name(s)
Relocation from HA to LA
Intervention Description
Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes
Primary Outcome Measure Information:
Title
Pulmonary artery Pressure (PAP) in the morning of second day at sea level (LA)
Description
Change in PAP in mmHg assessed by echocardiography between LA (sea level) vs High altitude (HA)
Time Frame
in the morning of the second day at sea level
Secondary Outcome Measure Information:
Title
Cardiac output in the morning of the second day at sea level
Description
Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840 m)
Time Frame
in the morning of the second day at sea level
Title
Cardiac output in the morning of the third day at sea level
Description
Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840m)
Time Frame
in the morning of the third day at sea level
Title
Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level
Description
Tricuspid pressure gradient assessed by echocardiography between LA (sea level) vs HA (2840m)
Time Frame
in the morning of the second day at sea level
Title
Tricuspid pressure gradient by echocardiography in the morning of the third day at sea level
Description
Tricuspid pressure gradient assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)
Time Frame
in the morning of the third day at sea level
Title
Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level
Description
Tricupsid annular plane systolic excursion assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)
Time Frame
in the morning of the third day at sea level
Title
Tricupsid annular plane systolic excursion by echocardiography in the morning of the third day at sea level
Description
Tricupsid annular plane systolic excursion by echocardiography assessed by between LA (sea level) vs HA (2840m)
Time Frame
in the morning of the third day at sea level
Title
ph by arterial blood gases in the morning of the second day at sea level
Description
Change in ph by arterial blood gases assessed between LA (sea level) vs HA (2840m)
Time Frame
in the morning of the second day at sea level
Title
partial pressure of oxygen (PaO2) by arterial blood gases in the morning of the second day at sea level
Description
Change in partial pressure of oxygen (PaO2) assessed by arterial blood gases between LA (sea level) vs HA (2840m)
Time Frame
in the morning of the second day at sea level
Title
partial pressure of carbon dioxide (PaCO2) by arterial blood gases in the morning of the second day at sea level
Description
Change in partial pressure of carbon dioxide (PaCO2) assessed by arterial blood gases partial pressure of carbon dioxide (PaCO2) between LA (sea level) vs HA (2840m)
Time Frame
in the morning of the second day at sea level
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients 18-90 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 pulse-oximetry (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)
Facility Information:
Facility Name
Respiratory Clinic, University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request to the PI and after publication of results, data will be shared upon reasonable research questions and ethical approval
Learn more about this trial
High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
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