Clinical trial NCT06489717: High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), SDB Assessed at HA (3200 m) vs LA (760 m)
Official title: Comparative Study of Sleep Disordered Breathing (SDB) in Patients With High Altitude Pulmonary Hypertension Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200 m vs. at Low Altitude (LA) 760 m
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High Altitude Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Hypoxia
High Altitude
Sleep disordered breathing
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 be assessed for SDB at 3200 m and at 760 m according to a prospective study design
Primary purpose: SUPPORTIVE_CARE

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 sleep disordered breathing

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 nocturnal respiratory sleep studies near their living altitude in Aksay at 3200 m and on night 1 and 6 at 760m 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: Mean nocturnal SpO2 during the first night at LA vs HA
timeFrame: night 1 at 760 m compared to 3200 m.
Secondary outcomes:
measure: Mean nocturnal SpO2 during the sixth night at LA vs HA
timeFrame: night 6 at 760 m compared to 3200 m.
measure: Time spent with SpO2<90% at LA vs HA
timeFrame: night 1 and night 6 at 760 m compared to 3200 m.
measure: AHI at LA vs HA
timeFrame: night 1 and night 6 at 760 m compared to 3200 m.
measure: ODI at LA vs. HA
timeFrame: night 1 and night 6 at 760 m compared to 3200 m.
measure: Time spent with periodic breathing at LA vs. HA
timeFrame: night 1 and night 6 at 760 m compared to 3200 m.
measure: Heart rate variability at LA vs. HA
timeFrame: night 1 and night 6 at 760 m compared to 3200 m.
measure: ECG markers of repolarization at LA vs. HA
timeFrame: night 1 and night 6 at 760 m compared to 3200 m.
measure: pulse transit time drops at LA vs. HA
timeFrame: night 1 and night 6 at 760 m compared to 3200 m.
Other outcomes:
Locations:
city: Aksay Plateau, Naryn, 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: