Clinical trial NCT06489704: High Altitude (HA) Residents With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Artery Pressure (PAP) Assessed at HA (3200 m) vs LA (760 m)
Official title: Comparative Study of Pulmonary Artery Pressure (PAP) Assessed by Echocardiography in Patients With High Altitude Pulmonary Hypertension (HAPH) Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200 m vs. at Low Altitude (LA) at 760 m
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High Altitude Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Hypoxia
High Altitude
Pulmonal Arterial Pressure
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Pulmonary artery Pressure (PAP) after the first night at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 at 760 m vs. 3200 m
Secondary outcomes:
measure: Change in Pulmonary artery Pressure (PAP) after seven nights at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 7 at 760 m vs. 3200 m
measure: Cardiac output at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 and 7 at 760 m vs. 3200 m
measure: Tricuspid pressure gradient by echocardiography at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 and 7 at 760 m vs. 3200 m
measure: Tricupsid annular plane systolic excursion by echocardiography at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 and 7 at 760 m vs. 3200 m
measure: pH by arterial blood gases at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 and 7 at 760 m vs. 3200 m
measure: partial pressure of oxygen (PaO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 and 7 at 760 m vs. 3200 m
measure: partial pressure of carbon dioxide (PaCO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)
timeFrame: after the first and seventh night at LA
measure: Change in right to left heart diameter ratio at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 and 7 at 760 m vs. 3200 m
measure: Change in right atrial area at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 and 7 at 760 m vs. 3200 m
measure: Change in right heart strain at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 and 7 at 760 m vs. 3200 m
measure: Change in ECG morphology at 760 m (LA) vs at 3200 m (HA)
timeFrame: day 2 and 7 at 760 m vs. 3200 m
Other outcomes:
Locations:
city: Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan
country: Kyrgyzstan
facility: Aksay Medical Center
Study officials:
affiliation: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
name: Talant M Sooronbaev, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: