Status:
UNKNOWN
HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)
Lead Sponsor:
University of Zurich
Conditions:
Pulmonary Vascular Disease
Pulmonary Artery Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
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 p...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05996302
Start Date
July 5 2023
End Date
December 31 2023
Last Update
October 3 2023
Active Locations (1)
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1
University Hospital Zurich
Zurich, Switzerland, 8091