Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Artery Hypertension, Pulmonary Vascular Disease
Conditions
Keywords
Pulmonary Hypertension, Hypoxia, sleep disordered breathing, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude
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 sleep disordered breathing
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 nocturnal respiratory sleep studies near their living altitude in Quito at 2840m and at sea level in Pedernales during the first and the second night after relocation.
Interventions
OTHERAssessment without intervention at High altitude
Assessments at High altitude corresponding to Baseline measures
OTHERRelocation to sea level for 2 days
Participants will be relocated to sea level and intervention and have assessements there.
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 2840m 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 cigarettes/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 |
|---|---|---|
| Mean nocturnal SpO2 at LA vs. HA | during the first night at low altitude (of intervention) | Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent with SpO2<90% at LA vs. HA | during the first and second night at low altitude (of intervention) | Change in time spent with SpO2\<90% between LA (sea level) vs HA (2840 m) |
| AHI at LA vs. HA | during the first and second night at low altitude (of intervention) | Change in apnea-hypopnea index (AHI) between LA (sea level) vs HA (2840 m) |
| ODI at LA vs. HA | during the first and second night at low altitude (of intervention) | Change in oxygen desaturation index (ODI) between LA (sea level) vs HA (2840 m) |
| Mean nocturnal SpO2 at LA vs. HA | during the second night at low altitude (of intervention) | Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m) |
| Heart rate variability at LA vs. HA | during the first and second night at low altitude (of intervention) | Change in heart rate variability between LA (sea level) vs HA (2840 m) |
| ECG markers of repolarization at LA vs. HA | during the first and second night at low altitude | Change in electrocardiogram (ECG) markers of repolarization (QT time) between LA (sea level) vs HA (2840 m) |
| pulse transit time drops at LA vs. HA | during the first and second night at low altitude | Change in pulse transit time drops between LA (sea level) vs HA (2840 m) |
| Time spent with periodic breathing at LA vs. HA | during the first and second night at low altitude (of intervention) | Change in time spent with periodic breathingbetween LA (sea level) vs HA (2840 m) |
Countries
Switzerland
Outcome results
None listed