HA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) 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 Pulmonary Artery Pressure (PAP) and Other Hemodynamics by Echocardiography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06084559
• Other study ID #: PVD_HA_SOT_PAP
• Status: Active, not recruiting
• Phase: N/A
• 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
• Study type: Interventional

Clinical Trial Summary

To study the effect of SOT in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics by echocardiography and in relation to blood gases at 2840m with and without SOT.

Description:

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 echocardiografy to assess PAP, cardiac output and other hemodynamics and arterial blood gas to assess SaO2, PaO2 and PaCO2 near their living altitude in Quito at 2840m whilst breathing ambient air or SOT at 10l/min flow via a face mask with reservoir.

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 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 Disorder
• Vascular Diseases

Intervention

Other:
• Supplemental oxygen therapy
Mobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied
• Sham Oxygen therapy
Patients will reveice pressurized air via a nasal cannula

Locations

Country	Name	City	State
Switzerland	University Hospital Zürich	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	Change in Pulmonary Artery Pressure with SOT vs. placebo	Change in PAP in mmHg assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask	at 15 min of breathing ambient air or supplemental oxygen
Secondary	Change in Cardiac Output with SOT vs. placebo	Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask	at 15 min of breathing ambient air or supplemental oxygen
Secondary	Change in right to left heart diameter ratio with SOT vs. placebo	Change in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask	at 15 min of breathing ambient air or supplemental oxygen
Secondary	Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo	Change in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air (placebo) 10l/min via facial mask	at 15 min of breathing ambient air or supplemental oxygen
Secondary	Change in right atrial area with SOT vs. placebo	Change in right atrial area by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask	at 15 min of breathing ambient air or supplemental oxygen
Secondary	Change in right heart strain with SOT vs. placebo	Change in in right heart strain by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask	at 15 min of breathing ambient air or supplemental oxygen
Secondary	Change in ph by arterial blood gases with SOT vs. placebo	Changes in ph by arterial blood gases SaO2, PaO2, PaCO2 with SOT compared to ambient air (placebo) 10l/min via facial mask	at 15 min of breathing ambient air or supplemental oxygen
Secondary	Change in PaO2 by arterial blood gases with SOT vs. placebo	Changes in PaO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask	at 15 min of breathing ambient air or supplemental oxygen
Secondary	Change in PaCO2 by arterial blood gases with SOT vs. placebo	Changes in PaCO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask	at 15 min of breathing ambient air or supplemental oxygen