Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Artery Hypertension, Pulmonary Vascular Disease
Conditions
Keywords
Pulmonary Hypertension, Hypoxia, 6-minute walk test, High altitude, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
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.
Interventions
BEHAVIORALRelocation to sea level
Relocation to sea level by bus and stay for 2 days
Sponsors
University of Zurich
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients living permanently \>2500m around Quito (Equador) will be assessed at 2850m and after relocation to sea level
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk distance (6MWD) after the first night at LA | after the first night at LA (sea level) | Change in 6MWD in meter between LA (sea level) vs HA (2840 m) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA | after the first night at LA (sea level) | 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 | after the second night at LA (sea level) | 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 | after the first night at LA (sea level) | Change in heart rate in bpm between LA (sea level) vs HA (2840 m) |
| 6-minute walk distance (6MWD) after the second night at LA | after the second night at LA (sea level) | Change in 6MWD in meter between LA (sea level) vs HA (2840 m) |
| Blood pressure at rest and at peak 6MWD after the first night at LA | after the first night at LA (sea level) | 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 | after the second night at LA (sea level) | Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m) |
| Heart rate at rest and at peak 6MWD after the second night at LA | after the second night at LA (sea level) | Change in heart rate in bpm between LA (sea level) vs HA (2840 m) |
Countries
Switzerland
Outcome results
None listed