High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)

• Sponsor: University of Zurich (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06092424
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.3
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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 pulmonary artery pressure (PAP) and other hemodynamics.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Vascular Disease; Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension	Behavioral: Relocation from HA to LA	N/A

Detailed Description

This research in 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 (PVD_HA) will have PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Patients will be investigated at high altitude (HA, 2840m) and low altitude (LA, sea level)Patients will be investigated at high altitude (HA, 2840m) and low altitude (LA, sea level)
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparative Study of Pulmonary Artery Pressure (PAP) and Other Hemodynamics Assessed by Echocardiography in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level
• Actual Study Start Date: Sep 23, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Investigations at High altitude (HA, 2840m) PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m	Behavioral: Relocation from HA to LA; Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes
Experimental: Investigations at Low altitude (LA, sea level) PAP and other hemodynamics assessed by echocardiography and blood gases after the first and second night at LA (sea level)	Behavioral: Relocation from HA to LA; Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes

Outcome Measures

Primary Outcome Measures

1. Pulmonary artery Pressure (PAP) in the morning of second day at sea level (LA) [in the morning of the second day at sea level]

   Change in PAP in mmHg assessed by echocardiography between LA (sea level) vs High altitude (HA)

Secondary Outcome Measures

1. Cardiac output in the morning of the second day at sea level [in the morning of the second day at sea level]

   Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840 m)

2. Cardiac output in the morning of the third day at sea level [in the morning of the third day at sea level]

   Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840m)

3. Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level [in the morning of the second day at sea level]

   Tricuspid pressure gradient assessed by echocardiography between LA (sea level) vs HA (2840m)

4. Tricuspid pressure gradient by echocardiography in the morning of the third day at sea level [in the morning of the third day at sea level]

   Tricuspid pressure gradient assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)

5. Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level [in the morning of the third day at sea level]

   Tricupsid annular plane systolic excursion assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)

6. Tricupsid annular plane systolic excursion by echocardiography in the morning of the third day at sea level [in the morning of the third day at sea level]

   Tricupsid annular plane systolic excursion by echocardiography assessed by between LA (sea level) vs HA (2840m)

7. ph by arterial blood gases in the morning of the second day at sea level [in the morning of the second day at sea level]

   Change in ph by arterial blood gases assessed between LA (sea level) vs HA (2840m)

8. partial pressure of oxygen (PaO2) by arterial blood gases in the morning of the second day at sea level [in the morning of the second day at sea level]

   Change in partial pressure of oxygen (PaO2) assessed by arterial blood gases between LA (sea level) vs HA (2840m)

9. partial pressure of carbon dioxide (PaCO2) by arterial blood gases in the morning of the second day at sea level [in the morning of the second day at sea level]

   Change in partial pressure of carbon dioxide (PaCO2) assessed by arterial blood gases partial pressure of carbon dioxide (PaCO2) between LA (sea level) vs HA (2840m)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients 18-90 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 pulse-oximetry (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	Respiratory Clinic, University Hospital of Zurich	Zurich		Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT06092424
• Other Study ID Numbers: PVD_HAvsLA_PAP
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Zurich: pulmonary hypertension; Pulmonary Vascular Disease; Chronic Thromboembolic Pulmonary Hypertension; high altitude; hypoxia; pulmonary artery pressure; arterial blood gases
• Additional relevant MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Vascular Diseases

Study Results

No Results Posted as of Oct 23, 2023