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

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06072417
• Other study ID #: PVD_HAvsLA_SDB
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Artery Hypertension
• Pulmonary Vascular Disease
• Vascular Diseases

Intervention

Other:
• Assessment without intervention at High altitude
Assessments at High altitude corresponding to Baseline measures
• Relocation to sea level for 2 days
Participants will be relocated to sea level and intervention and have assessements there.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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