Clinical trial NCT06489691: High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), 6MWT Assessed at High Altitude (3200m) vs Low Altitude (760m)
Official title: Comparative Study of 6-minute Walk Distance (6MWD) in Patients With High Altitude Pulmonary Hypertension Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200m vs. at Low Altitude (LA) 760m
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High Altitude Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Hypoxia
High Altitude
6-Minute Walk Test
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each highlander with HAPH will perform a 6 MWT at 3200 m and at 760 m according to a prospective study design
Primary purpose: OTHER

Brief summary: To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live \>2500m on 6-minute walk distance (6MWD)

Detailed description: This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA \>30 mmHg who permanently live at HA \>2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m and on day 2 and 7 at 760 m after relocation

Eligibility criteria: 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)

Primary outcomes:
measure: 6-minute walk distance (6MWD) on day 2 of relocation to 760 m
timeFrame: day 2 at 760 m compared to 3200 m
Secondary outcomes:
measure: 6-minute walk distance (6MWD) on day 7 of relocation to 760 m
timeFrame: day 7 at 760 m compared to 3200 m
measure: Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 2 of relocation to 760 m
timeFrame: day 2 at 760 m compared to 3200 m
measure: Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 7 of relocation to 760 m
timeFrame: day 7 at 760 m compared to 3200 m
measure: Heart rate at rest and at peak 6MWD on day 2 of relocation to 760 m
timeFrame: after the first night at LA (760 m)
measure: Heart rate at rest and at peak 6MWD on day 7 of relocation to 760 m
timeFrame: day 7 at 760 m compared to 3200 m
measure: Blood pressure at rest and at 6MWD on day 2 of relocation to 760 m
timeFrame: day 2 at 760 m compared to 3200 m
measure: Blood pressure at rest and at 6MWD on day 7 of relocation to 760 m
timeFrame: day 7 at 760 m compared to 3200 m
measure: Borg Dyspnea scale at end 6MWT on day 2 of relocation to 760 m
timeFrame: day 2 at 760 m compared to 3200 m
measure: Borg Dyspnea scale at end 6MWT on day 7 of relocation to 760 m
timeFrame: day 7 at 760 m compared to 3200 m
measure: Borg leg fatigue scale at end 6MWT on day 2 of relocation to 760 m
timeFrame: day 2 at 760 m compared to 3200 m
measure: Borg leg fatigue scale at end 6MWT on day 7 of relocation to 760 m
timeFrame: day 7 at 760 m compared to 3200 m
Other outcomes:
Locations:
city: Aksay Plateau, Naryn, Kyrgyzstan
country: Kyrgyzstan
facility: Aksay Medical Center
Study officials:
affiliation: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
name: Talant M Sooronbaev, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: