ECG Abnormalities, Heart Rate Variability (HRV), High Altitude, High Altitude Effects, Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Conditions
Keywords
Pulmonary hypertension, Pulmonary arterial hypertension PAH, Pulmonary vascular disease, High altitude, Heart rate variability, ECG, Arrythmias, Pulse transit time
Brief summary
To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level and re-ascent from sea level to 2850m on heart rate variability and other hemodynamic parameters in patients with pulmonary arterial hypertension PAH, who live permanently \>2600m.
Detailed description
The aim of this research is to investigate the heart rate variability and other hemodynamic outcomes during the descent from 2850m to sea level and during re-ascent from sea level to 2850m in patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m
Interventions
BEHAVIORALDescent and re-ascent (2850m, sea level)
Descent from 2850m to sea level (in one day by bus) and re-ascent after 7 days from sea level to 2850m (in one day by bus)
Sponsors
Silvia Ulrich Somaini
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed during descent from 2850m to sea level and during re-ascent after one week from sea level to 2850m
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18-80 years and of all genders * Permanent residence \> 2600 m * Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines * Patients are stable on therapy * NYHA (new york heart association) functional class I-III. * 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 \< 2600m. * Patients who traveled and stayed overnight at altitudes \<2000 m in the past 4 weeks. * 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 having persistent SpO2 (oxygen saturation by pulseoximetry) \<80% on ambient air. * 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 |
|---|---|---|
| Heart rate variability HRV during descent and re-ascent | From day of descent (day 1) and day of re-ascent (day 8) | Difference/change in heart rate variability at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 during descent and re-ascent | From day of descent (day 1) and day of re-ascent (day 8) | Difference/change in SpO2 at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension |
| ECG-Repolarization during descent and re-ascent | From day of descent (day 1) and day of re-ascent (day 8) | Difference/change in ECG-repolarization at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension |
| Cardial arrhythmias during descent and re-ascent | From day of descent (day 1) and day of re-ascent (day 8) | Occurrence/changes in cardial arrhythmias at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension |
| Pulse transit time during descent and re-ascent | From day of descent (day 1) and day of re-ascent (day 8) | Occurrence and difference/change in pulse transit time (drops) at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension |
Countries
Switzerland
Contacts
CONTACTSilvia Ulrich, Prof. Dr. med.
CONTACTMichael Furian, Prof. Dr. sc. ETH
PRINCIPAL_INVESTIGATORSilvia Ulrich
University Hospital Zurich, Departement of Pulmonology
PRINCIPAL_INVESTIGATORRodrigo Hoyos
Hospital Carlos Andrade Marin of Quito, Ecuador
Outcome results
None listed