Assessment of Six-minute Walking Distance 6MWD Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH

NCT07804472 | Not Yet Recruiting

• 1 other identifier: Ec_HAvsLA_6MWD_PAH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect of relocation from high altitude (Quito: 2850m) to sea level on six-minute walking distance and scores in patients with pulmonary arterial hypertension PAH, who live permanently \>2600m.

Conditions

Pulmonary Arterial Hypertension (PAH); Pulmonary Vascular Disease; Six-minute Walk Test; High Altitude Effects; High Altitude

Keywords

Hypoxia; High Altitude; Pulmonary Hypertension; 6-minute walking distance; Pulmonary Arterial Hypertension; NYHA

Outcome Measures

Primary Outcomes (1)

• Six-minute walking distance (m) after 7 days at sea level

  Difference/change in six-minute walking distance 6MWD between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

  From high altitude (2850m) to day 5-7 at sea level

Secondary Outcomes (15)

• SpO2 (peripheral oxygen saturation, %) at rest and end-exercise after 7 days at sea level

  From high altitude (2850m) to day 5-7 at sea level

• Heart rate (beats per minute) at rest and end-exercise after 7 days at sea level

  From high altitude (2850m) to day 5-7 at sea level

• Blood pressure (mmHg) at rest and end-exercise after 7 days at sea level

  From high altitude (2850m) to day 5-7 at sea level

• Dyspnea and leg discomfort sensation after 7 days at sea level

  From high altitude (2850m) to day 5-7 at sea level

• NYHA functional class (1-4) after 7 days at sea level

  From high altitude (2850m) to day 5-7 at sea level

Study Arms (1)

Six-minute walking distance 6MWD at 2850m and at sea level

EXPERIMENTAL

Assessment of the six-minute walking distance and scores near their resident altitude at 2850m followed by a descent from 2850m to sea level by bus with a stay for 7 days and again assessment of the same outcomes

Behavioral: Descent from 2850m to sea level

Interventions

Descent from 2850m to sea level BEHAVIORAL

Descent from 2850m to sea level with stay for 7 days

Six-minute walking distance 6MWD at 2850m and 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 aged 18-80 years and of all genders
• Permanent residence \> 2600 m
• Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines
• Patients are stable on therapy
• NYHA (new york heart association) functional class I-III
• 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 \< 2600m
• Patients who traveled and stayed overnight at altitudes \<2000 m in the past 4 weeks
• 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 having persistent SpO2 (oxygen saturation by pulse-oximetry) \<80% on ambient air.
• 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

• Silvia Ulrich Somaini: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Altitude Sickness; Hypoxia; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Silvia Ulrich

  University Hospital Zurich, Departement of Pulmonology

  PRINCIPAL INVESTIGATOR

• Rodrigo Hoyos

  Hospital Carlos Andrade Marin of Quito, Ecuador

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Ulrich, Prof. Dr. med.

CONTACT

+41442552220; silvia.ulrich@usz.ch

Michael Furian, Prof. Dr. sc. ETH

CONTACT

+41442552220

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Patients diagnosed with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m and after descent to sea level

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 4, 2026
• Study Start: September 25, 2026
• Primary Completion: October 4, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)