Chronic Thromboembolic Pulmonary Hypertension Clinical Trial
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.
Verified date | October 2023 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-minute walk distance (6MWD) after the first night at LA | Change in 6MWD in meter between LA (sea level) vs HA (2840 m) | after the first night at LA (sea level) | |
Secondary | 6-minute walk distance (6MWD) after the second night at LA | Change in 6MWD in meter between LA (sea level) vs HA (2840 m) | after the second night at LA (sea level) | |
Secondary | Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA | Change in SpO2 in % between LA (sea level) vs HA (2840 m) | after the first night at LA (sea level) | |
Secondary | Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA | Change in SpO2 in % between LA (sea level) vs HA (2840 m) | after the second night at LA (sea level) | |
Secondary | Heart rate at rest and at peak 6MWD after the first night at LA | Change in heart rate in bpm between LA (sea level) vs HA (2840 m) | after the first night at LA (sea level) | |
Secondary | Heart rate at rest and at peak 6MWD after the second night at LA | Change in heart rate in bpm between LA (sea level) vs HA (2840 m) | after the second night at LA (sea level) | |
Secondary | Blood pressure at rest and at peak 6MWD after the first night at LA | Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m) | after the first night at LA (sea level) | |
Secondary | Blood pressure at rest and at peak 6MWD after the second night at LA | Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m) | after the second night at LA (sea level) |
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