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

NCT06072417 | Unknown

• 1 other identifier: PVD_HAvsLA_SDB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Pulmonary Hypertension; Hypoxia; sleep disordered breathing; Pulmonary arterial hypertension; Chronic Thromboembolic Pulmonary Hypertension; High altitude

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mean nocturnal SpO2 at LA vs. HA

  during the second night at low altitude (of intervention)

• Time spent with SpO2<90% at LA vs. HA

  during the first and second night at low altitude (of intervention)

• AHI at LA vs. HA

  during the first and second night at low altitude (of intervention)

• ODI at LA vs. HA

  during the first and second night at low altitude (of intervention)

• Time spent with periodic breathing at LA vs. HA

  during the first and second night at low altitude (of intervention)

Study Arms (2)

Respiratory sleep study at 2840m

PLACEBO COMPARATOR

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

Other: Assessment without intervention at High altitude

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

EXPERIMENTAL

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

Other: Relocation to sea level for 2 days

Interventions

Assessment without intervention at High altitude OTHER

Assessments at High altitude corresponding to Baseline measures

Respiratory sleep study at 2840m

Relocation to sea level for 2 days OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Hypoxia; Sleep Apnea Syndromes; Pulmonary Arterial Hypertension; Altitude Sickness

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Silvia Ulrich, Prof. Dr.

  University Hospital Zurich, Departement of Pulmonology

  PRINCIPAL INVESTIGATOR

• Rodrigo Hoyos, Dr.

  Carlos Adrade Marin Hospital of Quito, Equador

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients living permanently \>2500m around Quito (Equador) will be assessed at 2840m and after relocation to sea level

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: October 10, 2023
• Study Start: September 22, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)