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Active, not recruitingNCT06072417Updated Oct 10, 2023

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

An interventional study of Assessment without intervention at High altitude and Relocation to sea level for 2 days in Pulmonary Vascular Disease, Pulmonary Artery Hypertension and Chronic Thromboembolic Pulmonary Hypertension, sponsored by University of Zurich. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by University of Zurich · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • 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
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 24 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherAssessment without intervention at High altitude

    Assessments at High altitude corresponding to Baseline measures

  • OtherRelocation to sea level for 2 days

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

06

What researchers measure

Primary outcomes

  1. Mean nocturnal SpO2 at LA vs. HA

    Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)

    Time frame: during the first night at low altitude (of intervention)

Secondary outcomes

  1. Mean nocturnal SpO2 at LA vs. HA

    Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)

    Time frame: during the second night at low altitude (of intervention)

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

    Change in time spent with SpO2\<90% between LA (sea level) vs HA (2840 m)

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

  3. AHI at LA vs. HA

    Change in apnea-hypopnea index (AHI) between LA (sea level) vs HA (2840 m)

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

  4. ODI at LA vs. HA

    Change in oxygen desaturation index (ODI) between LA (sea level) vs HA (2840 m)

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

  5. Time spent with periodic breathing at LA vs. HA

    Change in time spent with periodic breathingbetween LA (sea level) vs HA (2840 m)

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

  6. Heart rate variability at LA vs. HA

    Change in heart rate variability between LA (sea level) vs HA (2840 m)

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

  7. 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)

    Time frame: during the first and second night at low altitude

  8. pulse transit time drops at LA vs. HA

    Change in pulse transit time drops between LA (sea level) vs HA (2840 m)

    Time frame: during the first and second night at low altitude

07

Study locations

1 site
  • University Hospital Zurich
    Zurich, 8091, Switzerland
08

References and documents

Individual participant data

Plan to share: Yes — Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06072417
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Oct 10, 2023
Start date
Sep 22, 2023
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Oct 10, 2023

Study contacts

Silvia Ulrich, Prof. Dr.
principal investigator · University Hospital Zurich, Departement of Pulmonology
Rodrigo Hoyos, Dr.
principal investigator · Carlos Adrade Marin Hospital of Quito, Equador

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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