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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2023-12-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Pulmonary Vascular Disease Pulmonary Artery Hypertension Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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6-minute walk distance at 2840m

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

Group Type ACTIVE_COMPARATOR

Relocation to sea level

Intervention Type BEHAVIORAL

Relocation to sea level by bus and stay for 2 days

6-minute walk distance at sea level

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

Group Type EXPERIMENTAL

Relocation to sea level

Intervention Type BEHAVIORAL

Relocation to sea level by bus and stay for 2 days

Interventions

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Relocation to sea level

Relocation to sea level by bus and stay for 2 days

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No