Back to resultsHA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)
Primary Purpose
Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Relocation to sea level
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Vascular Disease focused on measuring Pulmonary Hypertension, Hypoxia, 6-minute walk test, High altitude, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Eligibility 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 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines Patients stable on therapy NYHA (new york heart association) 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 igarettes/day) Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) <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 Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
6-minute walk distance at 2840m
6-minute walk distance at sea level
Arm Description
Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m
Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m)
Outcomes
Primary Outcome Measures
6-minute walk distance (6MWD) after the first night at LA
Change in 6MWD in meter between LA (sea level) vs HA (2840 m)
Secondary Outcome Measures
6-minute walk distance (6MWD) after the second night at LA
Change in 6MWD in meter between LA (sea level) vs HA (2840 m)
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA
Change in SpO2 in % between LA (sea level) vs HA (2840 m)
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA
Change in SpO2 in % between LA (sea level) vs HA (2840 m)
Heart rate at rest and at peak 6MWD after the first night at LA
Change in heart rate in bpm between LA (sea level) vs HA (2840 m)
Heart rate at rest and at peak 6MWD after the second night at LA
Change in heart rate in bpm between LA (sea level) vs HA (2840 m)
Blood pressure at rest and at peak 6MWD after the first night at LA
Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)
Blood pressure at rest and at peak 6MWD after the second night at LA
Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05996302
Brief Title
HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)
Official Title
Comparative Study of 6-minute Walk Distance (6MWD) 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
July 5, 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
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 6-minute walk distance (6MWD)
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 (PVDHA) will have 6-minute walk distance 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 Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Keywords
Pulmonary Hypertension, Hypoxia, 6-minute walk test, High altitude, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients living permanently >2500m around Quito (Equador) will be assessed at 2850m and after relocation to sea level
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
6-minute walk distance at 2840m
Arm Type
Active Comparator
Arm Description
Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m
Arm Title
6-minute walk distance at sea level
Arm Type
Experimental
Arm Description
Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m)
Intervention Type
Behavioral
Intervention Name(s)
Relocation to sea level
Intervention Description
Relocation to sea level by bus and stay for 2 days
Primary Outcome Measure Information:
Title
6-minute walk distance (6MWD) after the first night at LA
Description
Change in 6MWD in meter between LA (sea level) vs HA (2840 m)
Time Frame
after the first night at LA (sea level)
Secondary Outcome Measure Information:
Title
6-minute walk distance (6MWD) after the second night at LA
Description
Change in 6MWD in meter between LA (sea level) vs HA (2840 m)
Time Frame
after the second night at LA (sea level)
Title
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA
Description
Change in SpO2 in % between LA (sea level) vs HA (2840 m)
Time Frame
after the first night at LA (sea level)
Title
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA
Description
Change in SpO2 in % between LA (sea level) vs HA (2840 m)
Time Frame
after the second night at LA (sea level)
Title
Heart rate at rest and at peak 6MWD after the first night at LA
Description
Change in heart rate in bpm between LA (sea level) vs HA (2840 m)
Time Frame
after the first night at LA (sea level)
Title
Heart rate at rest and at peak 6MWD after the second night at LA
Description
Change in heart rate in bpm between LA (sea level) vs HA (2840 m)
Time Frame
after the second night at LA (sea level)
Title
Blood pressure at rest and at peak 6MWD after the first night at LA
Description
Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)
Time Frame
after the first night at LA (sea level)
Title
Blood pressure at rest and at peak 6MWD after the second night at LA
Description
Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)
Time Frame
after the second night at LA (sea level)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
Patients stable on therapy
NYHA (new york heart association) 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 igarettes/day)
Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) <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 Zurich
City
Zurich
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
HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)
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