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)

NCT06003244 | Unknown

• 1 other identifier: PVD_HA_SOT_6MWD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Vascular Disease; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Keywords

Pulmonary Hypertension; Hypoxia; Supplemental Oxygen Therapy; Pulmonary arterial hypertension; Chronic Thromboembolic Pulmonary Hypertension; High altitude; Pulmonary vascular disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m

  6 minutes

• Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m

  6 minutes

• Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m

  6 minutes

• Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m

  6 minutes

Study Arms (2)

Ambient air

ACTIVE COMPARATOR

Patient will perform tests on ambient air at 2840 m

Other: 6-minute walk distance (6MWD) test

SOT via nasal canula

EXPERIMENTAL

Supplemental oxygen therapy (SOT) at 3l/min will be provided via a nasal cannula from a small oxygen bottle carried on the back according to standard care

Other: 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)

Interventions

6-minute walk distance (6MWD) test OTHER

6-minute walk distance (6MWD) test will be performed according to clinical standards

Ambient air

6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal) OTHER

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

SOT via nasal canula

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

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Hypoxia; Pulmonary Arterial Hypertension; Altitude Sickness

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; Respiration Disorders

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: NONE
• 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: August 21, 2023
• Study Start: September 23, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)