HA Residents With PVD, 6MWD Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT06003244

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Vascular Disease Pulmonary Artery Hypertension Chronic Thromboembolic Pulmonary Hypertension	Other: 6-minute walk distance (6MWD) test Other: 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Each participant works as its own perfect controlEach participant works as its own perfect control

Masking:

None (Open Label)

Primary Purpose:

Other

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)

Actual Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ambient air Patient will perform 6MWD test on ambient air at 2840 m	Other: 6-minute walk distance (6MWD) test 6-minute walk distance (6MWD) test will be performed according to clinical standards
Experimental: SOT via nasal canula 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) 6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (3l/min, nasal)

Arm

Intervention/Treatment

Active Comparator: Ambient air

Patient will perform 6MWD test on ambient air at 2840 m

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

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

Experimental: SOT via nasal canula

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)

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

Outcome Measures

Primary Outcome Measures

6-minute walk distance (6MWD) with SOT vs. ambient air at 2840m [after 6 minute]
Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m

Secondary Outcome Measures

SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m [6 minutes]
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
Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m [6 minutes]
Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m [6 minutes]
Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m [6 minutes]
Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zürich	Zürich		Switzerland	8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator: Silvia Ulrich, Prof. Dr., University Hospital Zurich, Departement of Pulmonology
Principal Investigator: Rodrigo Hoyos, Dr., Carlos Adrade Marin Hospital of Quito, Equador