HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)
- Conditions
- Pulmonary Artery HypertensionChronic Thromboembolic Pulmonary HypertensionPulmonary Vascular Disease
- Interventions
- Behavioral: Relocation to sea level
- Registration Number
- NCT05996302
- Lead Sponsor
- University of Zurich
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 6-minute walk distance at 2840m Relocation to sea level Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m 6-minute walk distance at sea level Relocation to sea level Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m)
- Primary Outcome Measures
Name Time Method 6-minute walk distance (6MWD) after the first night at LA after the first night at LA (sea level) Change in 6MWD in meter between LA (sea level) vs HA (2840 m)
- Secondary Outcome Measures
Name Time Method 6-minute walk distance (6MWD) after the second night at LA after the second night at LA (sea level) Change in 6MWD in meter between LA (sea level) vs HA (2840 m)
Blood pressure at rest and at peak 6MWD after the first night at LA after the first night at LA (sea level) Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA after the second night at LA (sea level) Change in SpO2 in % between LA (sea level) vs HA (2840 m)
Heart rate at rest and at peak 6MWD after the first night at LA after the first night at LA (sea level) Change in heart rate in bpm between LA (sea level) vs HA (2840 m)
Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA after the first night at LA (sea level) Change in SpO2 in % between LA (sea level) vs HA (2840 m)
Heart rate at rest and at peak 6MWD after the second night at LA after the second night at LA (sea level) Change in heart rate in bpm between LA (sea level) vs HA (2840 m)
Blood pressure at rest and at peak 6MWD after the second night at LA after the second night at LA (sea level) Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zurich, Switzerland