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)

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:

Effect of Supplemental Oxygen Therapy (SOT) 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06003244
• Other study ID #: PVD_HA_SOT_6MWD
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 23, 2023
• Est. completion date: December 31, 2023

Study information

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

Clinical Trial Summary

The investigators aim to study the effect of SOT in participants 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) assessed at 2840m.

Description:

Participants 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 with and without SOT at 3l/min via nasal cannula according to a randomized cross-over design.

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

IInclusion 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 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines

• Patients stable on therapy

• New York Heart Association (NYHA) 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 oxygen saturation by pulseoximetry (SpO2) <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)

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Artery Hypertension
• Pulmonary Vascular Disease
• Vascular Diseases

Intervention

Other:
• 6-minute walk distance (6MWD) test
6-minute walk distance (6MWD) test will be performed according to clinical standards
• 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)
6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (3l/min, nasal)

Locations

Country	Name	City	State
Switzerland	University Hospital Zürich	Zürich

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) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m	Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m	after 6 minute
Secondary	SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m	Change of the arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m	6 minutes
Secondary	Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m	Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m	6 minutes
Secondary	Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m	Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m	6 minutes
Secondary	Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m	Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m	6 minutes