Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH

N/ANot Yet RecruitingNCT07804524

Silvia Ulrich Somaini20 enrolled

Overview

To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in patients with pulmonary arterial hypertension PAH, who live permanently \>2600m.

The aim of this research is to investigate the pulmonary resistance (sPAP/CO) by echocardiography and other hemodynamic outcomes before and after relocation (high altitude near their living altitude vs. sea level) in patients with diagnosed pulmonary arterial 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 Echocardiography

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 2850m 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

Pulmonary resistance (sPAP/CO) after 7 days at sea level

Difference in sPAP/CO by echocardiography between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to day 5-7 at sea level

Secondary Outcomes

Tricuspid regurgitation velocity TRV after 7 days at sea level

Difference in tricuspid regurgitation velocity TRV between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to day 5-7 at sea level

Cardiac output CO after 7 days at sea level

Difference/change in cardiac output CO between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850) to day 5-7 at sea level

Tricuspid annular plan systolic excursion TAPSE after 7 days at sea level

Difference/change in tricuspid annular plan systolic excursion TAPSE between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to day 5-7 at sea level

Right ventricular strain after 7 days at sea level

Difference/change in right ventricular strain between 2850m and day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to Day 5-7 at sea level

Right atrial pressure RAP after 7 days at sea level

Difference/change in right atrial pressure RAP between 2850m and day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to Day 5-7 at sea level

Fractional area change FAC after 7 days at sea level

Difference/change in fractional area change FAC between 2850m and day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850m) to Day 5-7 at sea level

PaO2 after 7 days at sea level

Difference/change in PaO2 (arterial blood gas analysis) between 2850m and sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850) to day 5-7 at sea level

PaCO2 after 7 days at sea level

Difference/change in PaCO2 (arterial blood gas analysis) between 2850m and sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850) to day 5-7 at sea level

Hemoglobin after 7 days at sea level

Difference/change in hemoglobin (arterial blood gas analysis) between 2850m and sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850) to day 5-7 at sea level

pH after 7 days at sea level

Difference/change in pH(arterial blood gas analysis) between 2850m and sea level in patients with pulmonary arterial hypertension

Time frame: From high altitude (2850) to day 5-7 at sea level

Acclimatization-Effect of pulmonary resistance (sPAP/CO) at sea level

Difference/change in pulmonary resistance (sPAP/CO) within a stay at sea level of 7 days (after relocation from high altitude)