Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Patients With Pulmonary Arterial Hypertension PAH

NCT07804576 | Not Yet Recruiting

• 1 other identifier: Ec_LAvsHA_Lufu_PAH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect of a re-ascent to high altitude (Quito Ecuador: 2850m) after a one-week stay at sea level (after prior descent from 2850m) on lung function and pulmonary resistance/reactance in patients with pulmonary arterial disease PAH, who live permanently \> 2600m.

Conditions

Pulmonary Arterial Hypertension (PAH); Pulmonary Vascular Disease; High Altitude Effects; High Altitude; Lung Function Testing; Lung Function Changes

Keywords

Pulmonary arterial hypertension PAH; Pulmonary vascular disease; High Altitude; Lung function; forced oscillation technique

Outcome Measures

Primary Outcomes (1)

• FEV1 after re-ascent to 2850m

  Difference/change in forced expiratory volume in one second FEV1 between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension

  From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)

Secondary Outcomes (17)

• Forced Vital Capacity FVC after re-ascent to 2850m

  From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)

• FEV1/FVC after re-ascent to 2850m

  From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)

• Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m

  From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)

• Respiratory resistance (forced oscillation technique) after re-ascent to 2850m

  From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)

• Respiratory reactance (forced oscillation technique) after re-ascent to 2850m

  From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)

Study Arms (1)

Lung function at sea level and at 2850m

EXPERIMENTAL

Assessment of lung function and pulmonary resistance/reactance on day four at sea level (after prior descent from 2850m) and after re-ascent (after totally one week at sea level) back to 2850m by bus (in one day)

Behavioral: Re-ascent from sea level to 2850m

Interventions

Re-ascent from sea level to 2850m BEHAVIORAL

Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m

Lung function at sea level and at 2850m

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 aged 18-80 years and of all genders
• Permanent residence \> 2600 m
• Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines
• Patients are stable on therapy
• NYHA (new york heart association) functional class I-III.
• 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 \< 2600m.
• Patients who traveled and stayed overnight at altitudes \<2000 m in the past 4 weeks.
• 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 having persistent SpO2 (oxygen saturation by pulseoximetry) \<80% on ambient air.
• 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

• Silvia Ulrich Somaini: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Altitude Sickness

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Silvia Ulrich

  University Hospital Zurich, Departement of Pulmonology

  PRINCIPAL INVESTIGATOR

• Rodrigo Hoyos

  Hospital Carlos Andrade Marin of Quito, Ecuador

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Ulrich, Prof. Dr. med.

CONTACT

+41442552220; silvia.ulrich@usz.ch

Michael Furian, Prof. Dr. sc. ETH

CONTACT

+41442552220

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Patients with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m, after relocation to sea level for 7 days and after re-ascent

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 4, 2026
• Study Start: September 25, 2026
• Primary Completion: October 4, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)