Clinical trial NCT05996302: HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)
Official title: Comparative Study of 6-minute Walk Distance (6MWD) 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 Artery Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Hypoxia
6-minute walk test
High altitude
Pulmonary Artery Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients living permanently \>2500m around Quito (Equador) will be assessed at 2850m and after relocation to 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 6-minute walk distance (6MWD)

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 6-minute walk distance 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 18-80 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:

* 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 igarettes/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)

Primary outcomes:
measure: 6-minute walk distance (6MWD) after the first night at LA
timeFrame: after the first night at LA (sea level)
Secondary outcomes:
measure: 6-minute walk distance (6MWD) after the second night at LA
timeFrame: after the second night at LA (sea level)
measure: Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA
timeFrame: after the first night at LA (sea level)
measure: Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA
timeFrame: after the second night at LA (sea level)
measure: Heart rate at rest and at peak 6MWD after the first night at LA
timeFrame: after the first night at LA (sea level)
measure: Heart rate at rest and at peak 6MWD after the second night at LA
timeFrame: after the second night at LA (sea level)
measure: Blood pressure at rest and at peak 6MWD after the first night at LA
timeFrame: after the first night at LA (sea level)
measure: Blood pressure at rest and at peak 6MWD after the second night at LA
timeFrame: after the second night at LA (sea level)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital Zurich, Departement of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carlos Adrade Marin Hospital of Quito, Equador
name: Rodrigo Hoyos, Dr.
role: PRINCIPAL_INVESTIGATOR
References: