High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), 6MWT Assessed at High Altitude (3200m) vs Low Altitude (760m)

Not Applicable

Not yet recruiting

• Conditions: High Altitude Pulmonary Hypertension
• Interventions: Other: 6-minute walk test (6MWT)

• Registration Number: NCT06489691
• Lead Sponsor: University of Zurich

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

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study Start: 2024-07-01
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assessments at 3200 m and 760 m, respectively	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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 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)
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)
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)
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)
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)

Trial Locations

Locations (1)

Aksay Medical Center; 🇰🇬 Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan