High Altitude Pulmonary Hypertension
Conditions
Keywords
Pulmonary Hypertension, Hypoxia, High Altitude, Supplemental Oxygen Therapy, 6-Minute Walk Test
Brief summary
The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live \>2500m on 6-minute walk distance (6MWD) assessed at 3200m.
Detailed description
Highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA (Tricuspid Regurgitation Pressure Gradient) \>30 mmHg will be recruited for this project. Highlanders permanently living at HA \>2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m with and without portable pulsed supplemental oxygen therapy (SOT) via nasal cannula according to a randomized cross-over design.
Interventions
6-minute walk test (6MWT) will be performed according to clinical standards
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Each highlander with HAPH will perform a 6 MWT with and without SOT according to a cross-over design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Permanently living \>2500 m * HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m * Written informed consent
Exclusion criteria
* Highlanders who cannot follow the study investigations, * Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years. * Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months * Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m | after 6 minute | Change in 6MWD in meters between SOT vs. ambient air at 3200 m |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m | after 6 minute | Change of the arterial oxygen saturation by pulse oximetry (SpO2) at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m |
| Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m | after 6 minute | Change of the heart rate at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m |
| Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m | after 6 minute | Change of the blood pressure at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m |
| Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m | after 6 minute | Change of the Borg CR10 dyspnea scale at end of the 6MWT with SOT vs. ambient air at 3200 m |
| Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m | after 6 minute | Change of the Borg CR10 leg fatigue scale at end of the 6MWT with SOT vs. ambient air at 3200 m |
Countries
Kyrgyzstan
Contacts
PRINCIPAL_INVESTIGATORTalant MA Sooronbaev, Prof. Dr.
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
PRINCIPAL_INVESTIGATORSilvia Ulrich, Prof. Dr.
University Hospital Zurich, Department of Pulmonology
Outcome results
None listed