HA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)

NCT06084559 | Unknown

• 1 other identifier: PVD_HA_SOT_PAP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Vascular Disorder; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Keywords

pulmonary hypertension; hypoxia; supplemental oxygen; 6-minute walk distance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Cardiac Output with SOT vs. placebo

  at 15 min of breathing ambient air or supplemental oxygen

• Change in right to left heart diameter ratio with SOT vs. placebo

  at 15 min of breathing ambient air or supplemental oxygen

• Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo

  at 15 min of breathing ambient air or supplemental oxygen

• Change in right atrial area with SOT vs. placebo

  at 15 min of breathing ambient air or supplemental oxygen

• Change in right heart strain with SOT vs. placebo

  at 15 min of breathing ambient air or supplemental oxygen

Study Arms (2)

Placebo (ambient hypoxic air at 2840m)

SHAM COMPARATOR

Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir

Other: Sham Oxygen therapy

SOT (high flow supplemental oxygen therapy)

EXPERIMENTAL

SOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir

Other: Supplemental oxygen therapy

Interventions

Supplemental oxygen therapy OTHER

Mobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied

SOT (high flow supplemental oxygen therapy)

Sham Oxygen therapy OTHER

Patients will reveice pressurized air via a nasal cannula

Also known as: Placebo

Placebo (ambient hypoxic air at 2840m)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Muller J, Lichtblau M, Saxer S, Schmucki M, Furian M, Schneider SR, Herzig JJ, Bauer M, Saragoni D, Schwarz EI, Cajamarca E, Hoyos R, Ulrich S. The acute effect of high-dose supplemental oxygen on haemodynamics assessed by echocardiography in patients with pulmonary vascular disease living in Quito at 2850 m: a randomized, single-blind, placebo-controlled crossover trial. Eur Heart J Open. 2024 Dec 2;4(6):oeae097. doi: 10.1093/ehjopen/oeae097. eCollection 2024 Nov.

  PMID: 39698150 DERIVED

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Hypoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Silvia Ulrich, Prof. Dr.

  University Hospital Zurich, Departement of Pulmonology

  PRINCIPAL INVESTIGATOR

• Rodrigo Hoyos, Dr.

  Carlos Adrade Marin Hospital of Quito, Equador

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham SOT (placebo, ambient hypoxic air at 2840m) versus high-flow oxygen 10l/min both via a facial mask with reservoir will be applied
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant works as its own perfect control

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: October 16, 2023
• Study Start: July 5, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)