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
| Registry | NCT06489691 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, other |
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| Enrollment | 24 (Actual) |
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| Sponsor | University of Zurich (Other) |
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| Conditions | High Altitude Pulmonary Hypertension |
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| Interventions | 6-minute walk test (6MWT) (Other) |
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| Dates | start 2024-07-02, primary completion 2024-09-27, completion 2024-09-27, first posted 2024-07-08, last updated 2026-01-22 |
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| Locations | 1 site in Kyrgyzstan |
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Related Papers Related Patents Related Grants Related Experts
All trials for High Altitude Pulmonary Hypertension All trials of 6-minute walk test (6MWT)
-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)
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+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
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Assessments at 3200 m and 760 m, respectively | Experimental | Other: 6-minute walk test (6MWT) | Participants will have a 6-minute walk distance (6MWD) assessment near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days. |
- 6-minute walk test (6MWT) (Other): 6-minute walk test (6MWT) will be performed according to clinical standards
+Outcome measures
Primary outcomes
- 6-minute walk distance (6MWD) on day 2 of relocation to 760 m [day 2 at 760 m compared to 3200 m]: Change in 6MWD in meter between LA (760 m) vs HA (3200 m)
Secondary outcomes
- 6-minute walk distance (6MWD) on day 7 of relocation to 760 m [day 7 at 760 m compared to 3200 m]: 6-minute walk distance (6MWD) in meter between LA (760 m) and HA (3200 m)
- Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 2 of relocation to 760 m [day 2 at 760 m compared to 3200 m]: Change in SpO2 in % between LA (760 m) vs HA (3200 m)
- Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 7 of relocation to 760 m [day 7 at 760 m compared to 3200 m]: Change in SpO2 in % between LA (760 m) vs HA (3200 m)
- Heart rate at rest and at peak 6MWD on day 2 of relocation to 760 m [after the first night at LA (760 m)]: Change in hear rate in bpm between LA (760 m) vs HA (3200 m)
- Heart rate at rest and at peak 6MWD on day 7 of relocation to 760 m [day 7 at 760 m compared to 3200 m]: Change in hear rate in bpm between LA (760 m) vs HA (3200 m)
- Blood pressure at rest and at 6MWD on day 2 of relocation to 760 m [day 2 at 760 m compared to 3200 m]: Change in blood pressure in mmHg between LA (760 m) vs HA (3200 m)
- Blood pressure at rest and at 6MWD on day 7 of relocation to 760 m [day 7 at 760 m compared to 3200 m]: Change in blood pressure in mmHg between LA (760 m) vs HA (3200 m)
- Borg Dyspnea scale at end 6MWT on day 2 of relocation to 760 m [day 2 at 760 m compared to 3200 m]: Change of the Borg CR10 dyspnea scale at end of the 6MWT after the first night at LA (760 m) vs HA (3200 m)
- Borg Dyspnea scale at end 6MWT on day 7 of relocation to 760 m [day 7 at 760 m compared to 3200 m]: Change of the Borg CR10 dyspnea scale at end of the 6MWT after seven nights at LA (760 m) vs HA (3200 m)
- Borg leg fatigue scale at end 6MWT on day 2 of relocation to 760 m [day 2 at 760 m compared to 3200 m]: Change of the Borg CR10 leg fatigue scale at end of the 6MWT after the first night at LA (760 m) vs HA (3200 m)
- Borg leg fatigue scale at end 6MWT on day 7 of relocation to 760 m [day 7 at 760 m compared to 3200 m]: Change of the Borg CR10 leg fatigue scale at end of the 6MWT after seven nights at LA (760 m) vs HA (3200 m)
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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)
+Locations (1)
| Facility | City | Country | Status |
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| Aksay Medical Center | Aksay Plateau, Naryn, Kyrgyzstan | Kyrgyzstan | |
+Investigators