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

NCT ID: NCT06072417

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-22
• Study Completion Date: 2023-12-31

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.

Conditions

Pulmonary Vascular Disease; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Respiratory sleep study at 2840m

Participants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m

Group Type: PLACEBO_COMPARATOR

Assessment without intervention at High altitude

Intervention Type: OTHER

Assessments at High altitude corresponding to Baseline measures

Respiratory sleep study near sea level (0-30m)

Participants will have a respiratory sleep study by polygraphy near sea level (0-30m)

Group Type: EXPERIMENTAL

Relocation to sea level for 2 days

Intervention Type: OTHER

Participants will be relocated to sea level and intervention and have assessements there.

Interventions

Assessment without intervention at High altitude

Assessments at High altitude corresponding to Baseline measures

Intervention Type: OTHER

Relocation to sea level for 2 days

Participants will be relocated to sea level and intervention and have assessements there.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Ulrich, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Departement of Pulmonology

Rodrigo Hoyos, Dr.

Role: PRINCIPAL_INVESTIGATOR

Carlos Adrade Marin Hospital of Quito, Equador

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

PVD_HAvsLA_SDB

Identifier Type: -

Identifier Source: org_study_id