HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level)

Not Applicable

Active, not recruiting

• Conditions: Pulmonary Vascular Disease; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension
• Interventions: Other: Relocation to sea level for 2 days; Other: Assessment without intervention at High altitude

• Registration Number: NCT06072417
• Lead Sponsor: University of Zurich

Brief Summary

To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live \>2500m on sleep disordered breathing

Detailed Description

This research in patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA \>2500 (PVDHA) will have nocturnal respiratory sleep studies near their living altitude in Quito at 2840m and at sea level in Pedernales during the first and the second night after relocation.

Study Timeline

• Study First Submitted: 2023-08-09
• Study Start: 2023-09-22
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adult patients 18-80 years old of both genders,
• Residence > 2500m of altitude
• diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
• Patients stable on therapy
• NYHA (new york heart association) functional class I-III
• Provided written informed consent to participate in the study.

Exclusion Criteria

• Age <18 years or >80 years
• unstable condition
• Patients who cannot follow the study investigations, patient permanently living < 2500m.
• Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
• Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) <80% on ambient air.
• Patients with chronic mountain sickness (Hemoglobin > 19 g/dl in women, >21 g/dl in men)
• Patient with a non-corrected ventricular septum defect
• Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Respiratory sleep study near sea level (0-30m)	Relocation to sea level for 2 days	Participants will have a respiratory sleep study by polygraphy near sea level (0-30m)
Respiratory sleep study at 2840m	Assessment without intervention at High altitude	Participants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m

Primary Outcome Measures

Name	Time	Method
Mean nocturnal SpO2 at LA vs. HA	during the first night at low altitude (of intervention)	Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)

Secondary Outcome Measures

Name	Time	Method
pulse transit time drops at LA vs. HA	during the first and second night at low altitude	Change in pulse transit time drops between LA (sea level) vs HA (2840 m)
Time spent with SpO2<90% at LA vs. HA	during the first and second night at low altitude (of intervention)	Change in time spent with SpO2\<90% between LA (sea level) vs HA (2840 m)
Mean nocturnal SpO2 at LA vs. HA	during the second night at low altitude (of intervention)	Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)
Heart rate variability at LA vs. HA	during the first and second night at low altitude (of intervention)	Change in heart rate variability between LA (sea level) vs HA (2840 m)
AHI at LA vs. HA	during the first and second night at low altitude (of intervention)	Change in apnea-hypopnea index (AHI) between LA (sea level) vs HA (2840 m)
ECG markers of repolarization at LA vs. HA	during the first and second night at low altitude	Change in electrocardiogram (ECG) markers of repolarization (QT time) between LA (sea level) vs HA (2840 m)
ODI at LA vs. HA	during the first and second night at low altitude (of intervention)	Change in oxygen desaturation index (ODI) between LA (sea level) vs HA (2840 m)
Time spent with periodic breathing at LA vs. HA	during the first and second night at low altitude (of intervention)	Change in time spent with periodic breathingbetween LA (sea level) vs HA (2840 m)

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland