NCT06489704

Brief Summary

To study the effect of relocation from 3200 m (Aksay) to 760 m (Bishkek) in patients with high altitude pulmonary hypertension (HAPH) who permanently live \>2500 m on pulmonary artery pressure (PAP)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

July 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

June 28, 2024

Last Update Submit

January 19, 2026

Conditions

Keywords

Pulmonary HypertensionHypoxiaHigh AltitudePulmonal Arterial Pressure

Outcome Measures

Primary Outcomes (1)

  • Change in Pulmonary artery Pressure (PAP) after the first night at 760 m (LA) vs at 3200 m (HA)

    Change in RV/RA in mmHg assessed by echocardiography between LA (760 m) vs High altitude (3200 m)

    day 2 at 760 m vs. 3200 m

Secondary Outcomes (11)

  • Change in Pulmonary artery Pressure (PAP) after seven nights at 760 m (LA) vs at 3200 m (HA)

    day 7 at 760 m vs. 3200 m

  • Cardiac output at 760 m (LA) vs at 3200 m (HA)

    day 2 and 7 at 760 m vs. 3200 m

  • Tricuspid pressure gradient by echocardiography at 760 m (LA) vs at 3200 m (HA)

    day 2 and 7 at 760 m vs. 3200 m

  • Tricupsid annular plane systolic excursion by echocardiography at 760 m (LA) vs at 3200 m (HA)

    day 2 and 7 at 760 m vs. 3200 m

  • pH by arterial blood gases at 760 m (LA) vs at 3200 m (HA)

    day 2 and 7 at 760 m vs. 3200 m

  • +6 more secondary outcomes

Study Arms (1)

Assessments at 3200 m and 760 m, respectively

EXPERIMENTAL

Participants will have a echocardiography near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days

Other: Echocardiography

Interventions

Echocardiography will be performed according to clinical standards

Assessments at 3200 m and 760 m, respectively

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksay Medical Center

Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary edema of mountaineersHypertension, PulmonaryHypoxiaAltitude Sickness

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration 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
Model Details: Each highlander with HAPH will perform a echocardiography at high altitude (HA, 3200 m) and day 2 and day 7 at low altitude (LA, 760 m) according to a prospective study design
Sponsor Type
OTHER
Responsible Party
SPONSOR

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 21, 2026

Record last verified: 2026-01

Locations