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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05996302
Other study ID # PVD_HAvsLA_6MWD
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 5, 2023
Est. completion date December 31, 2023

Study information

Verified date October 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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 information / eligibility

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)

Study Design


Intervention

Behavioral:
Relocation to sea level
Relocation to sea level by bus and stay for 2 days

Locations

Country Name City State
Switzerland University Hospital Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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)
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT06003244 - High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT) N/A
Active, not recruiting NCT06072417 - HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level) N/A
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