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

N/ANot Yet RecruitingNCT07804576

Silvia Ulrich Somaini20 enrolled

Overview

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.

The aim of this research is to investigate the lung function and pulmonary resistance/reactance before and after re-ascent (sea level for 7 days after prior descent from 2850m vs. re-ascent to 2850m) in patients with diagnosed pulmonary hypertension according to guidelines, who permanently live at high altitude over 2600m.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension (PAH)Pulmonary Vascular Disease High Altitude Effects High Altitude

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Forced Vital Capacity FVC after re-ascent to 2850m

Difference/change in forced vital capacity FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension

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

FEV1/FVC after re-ascent to 2850m

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

Time frame: 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

Difference/change in respiratory impedance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension

Time frame: 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

Difference/change in respiratory resistance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension

Time frame: 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

Difference/change in respiratory reactance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension

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

FEV1 after 4 days at sea level

Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease

Time frame: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)

Forced Vital Capacity FVC after 4 days at sea level

Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease

Time frame: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)

FEV1/FVC after 4 days at sea level

Difference/change in FEV1/FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease

Time frame: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)

Respiratory Impedance (forced oscillation technique) after 4 days at sea level

Difference/change in respiratory impedance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease

Time frame: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)

Respiratory resistance (forced oscillation technique) after 4 days at sea level

Difference/change in respiratory resistance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease

Time frame: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)

Respiratory reactance (forced oscillation technique) after 4 days at sea level

Difference/change in respiratory reactance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease

Time frame: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)

FEV1 pre-descent and after re-ascent (2850m)

Difference/change in FEV1 at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial disease