Clinical trial NCT06092424: High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
Official title: Comparative Study of Pulmonary Artery Pressure (PAP) and Other Hemodynamics Assessed by Echocardiography in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Vascular Disease
Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Keywords: pulmonary hypertension
Pulmonary Vascular Disease
Chronic Thromboembolic Pulmonary Hypertension
high altitude
hypoxia
pulmonary artery pressure
arterial blood gases
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be investigated at high altitude (HA, 2840m) and low altitude (LA, sea level)
Primary purpose: SUPPORTIVE_CARE

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 pulmonary artery pressure (PAP) and other hemodynamics.

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 (PVD_HA) will have PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.

Eligibility criteria: Inclusion Criteria:

* Adult patients 18-90 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 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
* Patients stable on therapy
* New York Heart Association (NYHA) functional class I-III
* Provided 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 \< 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 oxygen saturation by pulse-oximetry (SpO2) \<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)

Primary outcomes:
measure: Pulmonary artery Pressure (PAP) in the morning of second day at sea level (LA)
timeFrame: in the morning of the second day at sea level
Secondary outcomes:
measure: Cardiac output in the morning of the second day at sea level
timeFrame: in the morning of the second day at sea level
measure: Cardiac output in the morning of the third day at sea level
timeFrame: in the morning of the third day at sea level
measure: Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level
timeFrame: in the morning of the second day at sea level
measure: Tricuspid pressure gradient by echocardiography in the morning of the third day at sea level
timeFrame: in the morning of the third day at sea level
measure: Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level
timeFrame: in the morning of the third day at sea level
measure: Tricupsid annular plane systolic excursion by echocardiography in the morning of the third day at sea level
timeFrame: in the morning of the third day at sea level
measure: ph by arterial blood gases in the morning of the second day at sea level
timeFrame: in the morning of the second day at sea level
measure: partial pressure of oxygen (PaO2) by arterial blood gases in the morning of the second day at sea level
timeFrame: in the morning of the second day at sea level
measure: partial pressure of carbon dioxide (PaCO2) by arterial blood gases in the morning of the second day at sea level
timeFrame: in the morning of the second day at sea level
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
References: