High Altitude (HA) Residents With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Artery Pressure (PAP) Assessed at HA (3200 m) vs LA (760 m)

Not Applicable

Not yet recruiting

• Conditions: High Altitude Pulmonary Hypertension
• Interventions: Other: Echocardiography

• Registration Number: NCT06489704
• Lead Sponsor: University of Zurich

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)

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 have pulmonary arterial pressure (PAP) assessed by echocardiography near their living altitude in Aksay at 3200 m and at 760 m in Bishkek the day after the first and the seventh night 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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assessments at 3200 m and 760 m, respectively	Echocardiography	Participants will have a echocardiography near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days

Primary Outcome Measures

Name	Time	Method
Change in Pulmonary artery Pressure (PAP) after the first night at 760 m (LA) vs at 3200 m (HA)	day 2 at 760 m vs. 3200 m	Change in RV/RA in mmHg assessed by echocardiography between LA (760 m) vs High altitude (3200 m)

Secondary Outcome Measures

Name	Time	Method
Tricuspid pressure gradient by echocardiography at 760 m (LA) vs at 3200 m (HA)	day 2 and 7 at 760 m vs. 3200 m	Tricuspid pressure gradient assessed by echocardiography between LA (760 m) vs HA (3200 m)
Change in right to left heart diameter ratio at 760 m (LA) vs at 3200 m (HA)	day 2 and 7 at 760 m vs. 3200 m	Change in right to left heart diameter ratio assessed by echocardiography between LA (760 m) vs HA (3200 m)
Change in ECG morphology at 760 m (LA) vs at 3200 m (HA)	day 2 and 7 at 760 m vs. 3200 m	Change in ECG morphology and QT-interval by 12-lead ECG between LA (760 m) vs HA (3200 m)
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	Change in RV/RA in mmHg assessed by echocardiography between LA (760 m) vs High altitude (3200 m)
partial pressure of oxygen (PaO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)	day 2 and 7 at 760 m vs. 3200 m	Change in partial pressure of oxygen (PaO2) assessed by arterial blood gases between LA (760 m) vs HA (3200 m)
Cardiac output at 760 m (LA) vs at 3200 m (HA)	day 2 and 7 at 760 m vs. 3200 m	Change in cardiac output in l/min assessed by echocardiography between LA (760 m) vs HA (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	Tricupsid annular plane systolic excursion assessed by echocardiography between LA (760 m) vs HA (3200 m)
partial pressure of carbon dioxide (PaCO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)	after the first and seventh night at LA	Change in partial pressure of carbon dioxide (PaCO2) assessed by arterial blood gases partial pressure of carbon dioxide (PaCO2) between LA (760 m) vs HA (3200 m)
Change in right heart strain at 760 m (LA) vs at 3200 m (HA)	day 2 and 7 at 760 m vs. 3200 m	Change in right heart strain by echocardiography between LA (760 m) vs HA (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	Change in pH by arterial blood gases assessed between LA (760 m) vs HA (3200 m)
Change in right atrial area at 760 m (LA) vs at 3200 m (HA)	day 2 and 7 at 760 m vs. 3200 m	Change in right atrial area by echocardiography between LA (760 m) vs HA (3200 m)

Trial Locations

Locations (1)

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