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

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

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)

Study Overview

• Status: Completed
• Conditions: High Altitude Pulmonary Hypertension
• Intervention / Treatment: Other: 6-minute walk test (6MWT)

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kyrgyzstan
  • Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan
    • Aksay Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assessments at 3200 m and 760 m, respectively; 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.	Other: 6-minute walk test (6MWT); 6-minute walk test (6MWT) will be performed according to clinical standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk distance (6MWD) on day 2 of relocation to 760 m	Change in 6MWD in meter between LA (760 m) vs HA (3200 m)	day 2 at 760 m compared to 3200 m

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk distance (6MWD) on day 7 of relocation to 760 m	6-minute walk distance (6MWD) in meter between LA (760 m) and HA (3200 m)	day 7 at 760 m compared to 3200 m
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 2 of relocation to 760 m	Change in SpO2 in % between LA (760 m) vs HA (3200 m)	day 2 at 760 m compared to 3200 m
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 7 of relocation to 760 m	Change in SpO2 in % between LA (760 m) vs HA (3200 m)	day 7 at 760 m compared to 3200 m
Heart rate at rest and at peak 6MWD on day 2 of relocation to 760 m	Change in hear rate in bpm between LA (760 m) vs HA (3200 m)	after the first night at LA (760 m)
Heart rate at rest and at peak 6MWD on day 7 of relocation to 760 m	Change in hear rate in bpm between LA (760 m) vs HA (3200 m)	day 7 at 760 m compared to 3200 m
Blood pressure at rest and at 6MWD on day 2 of relocation to 760 m	Change in blood pressure in mmHg between LA (760 m) vs HA (3200 m)	day 2 at 760 m compared to 3200 m
Blood pressure at rest and at 6MWD on day 7 of relocation to 760 m	Change in blood pressure in mmHg between LA (760 m) vs HA (3200 m)	day 7 at 760 m compared to 3200 m
Borg Dyspnea scale at end 6MWT on day 2 of relocation to 760 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)	day 2 at 760 m compared to 3200 m
Borg Dyspnea scale at end 6MWT on day 7 of relocation to 760 m	Change of the Borg CR10 dyspnea scale at end of the 6MWT after seven nights at LA (760 m) vs HA (3200 m)	day 7 at 760 m compared to 3200 m
Borg leg fatigue scale at end 6MWT on day 2 of relocation to 760 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)	day 2 at 760 m compared to 3200 m
Borg leg fatigue scale at end 6MWT on day 7 of relocation to 760 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)	day 7 at 760 m compared to 3200 m

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Silvia Ulrich, Prof. Dr., University Hospital Zurich, Department of Pulmonology; Principal Investigator: Talant M Sooronbaev, Prof. Dr., National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary Hypertension; Hypoxia; High Altitude; 6-Minute Walk Test
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Hypertension; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Hypertension, Pulmonary; Altitude Sickness; Pulmonary edema of mountaineers
• Other Study ID Numbers: HAPH_HAvsLA_6MWT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No