HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)

NCT05996302 | Unknown

• 1 other identifier: PVD_HAvsLA_6MWD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) 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)

Conditions

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

Keywords

Pulmonary Hypertension; Hypoxia; 6-minute walk test; High altitude; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 6-minute walk distance (6MWD) after the first night at LA

  Change in 6MWD in meter between LA (sea level) vs HA (2840 m)

  after the first night at LA (sea level)

Secondary Outcomes (7)

• 6-minute walk distance (6MWD) after the second night at LA

  after the second night at LA (sea level)

• Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA

  after the first night at LA (sea level)

• Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA

  after the second night at LA (sea level)

• Heart rate at rest and at peak 6MWD after the first night at LA

  after the first night at LA (sea level)

• Heart rate at rest and at peak 6MWD after the second night at LA

  after the second night at LA (sea level)

Study Arms (2)

6-minute walk distance at 2840m

ACTIVE COMPARATOR

Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m

Behavioral: Relocation to sea level

6-minute walk distance at sea level

EXPERIMENTAL

Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m)

Behavioral: Relocation to sea level

Interventions

Relocation to sea level BEHAVIORAL

Relocation to sea level by bus and stay for 2 days

6-minute walk distance at 2840m; 6-minute walk distance at sea level

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 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
• Patients stable on therapy
• NYHA (new york heart association) 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 igarettes/day)
• Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) \<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 Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Hypoxia; 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: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients living permanently \>2500m around Quito (Equador) will be assessed at 2850m and after relocation to sea level

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 18, 2023
• Study Start: July 5, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)