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

• Sponsor: University of Zurich (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05996302
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 4.1

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 6-minute walk distance (6MWD)

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Vascular Disease; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension	Behavioral: Relocation to sea level	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 (PVDHA) will have 6-minute walk distance 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: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Patients living permanently >2500m around Quito (Equador) will be assessed at 2850m and after relocation to sea levelPatients living permanently >2500m around Quito (Equador) will be assessed at 2850m and after relocation to sea level
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparative Study of 6-minute Walk Distance (6MWD) 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: 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: 6-minute walk distance at 2840m Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m	Behavioral: Relocation to sea level; Relocation to sea level by bus and stay for 2 days
Experimental: 6-minute walk distance at sea level Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m)	Behavioral: Relocation to sea level; Relocation to sea level by bus and stay for 2 days

Outcome Measures

Primary Outcome Measures

1. 6-minute walk distance (6MWD) after the first night at LA [after the first night at LA (sea level)]

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

Secondary Outcome Measures

1. 6-minute walk distance (6MWD) after the second night at LA [after the second night at LA (sea level)]

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

2. 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)]

   Change in SpO2 in % between LA (sea level) vs HA (2840 m)

3. 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)]

   Change in SpO2 in % between LA (sea level) vs HA (2840 m)

4. Heart rate at rest and at peak 6MWD after the first night at LA [after the first night at LA (sea level)]

   Change in heart rate in bpm between LA (sea level) vs HA (2840 m)

5. Heart rate at rest and at peak 6MWD after the second night at LA [after the second night at LA (sea level)]

   Change in heart rate in bpm between LA (sea level) vs HA (2840 m)

6. Blood pressure at rest and at peak 6MWD after the first night at LA [after the first night at LA (sea level)]

   Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)

7. Blood pressure at rest and at peak 6MWD after the second night at LA [after the second night at LA (sea level)]

   Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion 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 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.

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 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zurich		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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT05996302
• Other Study ID Numbers: PVD_HAvsLA_6MWD
• First Posted: Aug 18, 2023
• Last Update Posted: Aug 18, 2023
• Last Verified: Aug 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; Hypoxia; 6-minute walk test; High altitude; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension
• Additional relevant MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Vascular Diseases

Study Results

No Results Posted as of Aug 18, 2023