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

Comparative Study of Sleep Disordered Breathing (SDB) in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Vascular Disease
• Intervention / Treatment: Other: Assessment without intervention at High altitude; Other: Relocation to sea level for 2 days

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Respiratory sleep study at 2840m; Participants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m	Other: Assessment without intervention at High altitude; Assessments at High altitude corresponding to Baseline measures
Experimental: Respiratory sleep study near sea level (0-30m); Participants will have a respiratory sleep study by polygraphy near sea level (0-30m)	Other: Relocation to sea level for 2 days; Participants will be relocated to sea level and intervention and have assessements there.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Silvia Ulrich, Prof. Dr., University Hospital Zurich, Departement of Pulmonology; Principal Investigator: Rodrigo Hoyos, Dr., Carlos Adrade Marin Hospital of Quito, Equador

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary Hypertension; Hypoxia; Pulmonary arterial hypertension; sleep disordered breathing; High altitude; Chronic Thromboembolic Pulmonary Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Vascular Diseases; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: PVD_HAvsLA_SDB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No