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

NCT06489691 | Completed

• 1 other identifier: HAPH_HAvsLA_6MWT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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)

Conditions

High Altitude Pulmonary Hypertension

Keywords

Pulmonary Hypertension; Hypoxia; High Altitude; 6-Minute Walk Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 6-minute walk distance (6MWD) on day 7 of relocation to 760 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

  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

  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

  after the first night at LA (760 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

Study Arms (1)

Assessments at 3200 m and 760 m, respectively

EXPERIMENTAL

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)

Interventions

6-minute walk test (6MWT) OTHER

6-minute walk test (6MWT) will be performed according to clinical standards

Assessments at 3200 m and 760 m, respectively

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Aksay Medical Center

Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary edema of mountaineers; Hypertension, Pulmonary; Hypoxia; Altitude Sickness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Talant M Sooronbaev, Prof. Dr.

  National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

  PRINCIPAL INVESTIGATOR

• Silvia Ulrich, Prof. Dr.

  University Hospital Zurich, Department of Pulmonology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each highlander with HAPH will perform a 6 MWT at 3200 m and at 760 m according to a prospective study design

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: July 2, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

KY (1)