HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level) (NCT06072417) | Clinical Trial Compass
UnknownNot Applicable
HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level)
Switzerland24 participantsStarted 2023-09-22
Plain-language 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 sleep disordered breathing
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cigarettes/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)
What they're measuring
1
Mean nocturnal SpO2 at LA vs. HA
Timeframe: during the first night at low altitude (of intervention)