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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06072417
Other study ID # PVD_HAvsLA_SDB
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
See also
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