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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSilvia Ulrich Somaini

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years or >80 years

unstable condition

Patients who cannot follow the study investigations

Patient permanently living < 2600m

Trial design

Design model

Single group

Treatments tested in this trial

  • Descent from 2850m to sea level

    Behavioral

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Six-minute walking distance 6MWD at 2850m and at sea levelExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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

Difference/change in SpO2 (peripheral oxygen saturation) at rest and end-exercise between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame
From high altitude (2850m) to day 5-7 at sea level
2

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

Difference/change in heart rate at rest and end-exercise between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame
From high altitude (2850m) to day 5-7 at sea level
3

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

Difference/change in blood pressure at rest and end-exercise between 2850m and Day 5-7 at sea level in patients with pulmonary arterial hypertension

Time frame
From high altitude (2850m) to day 5-7 at sea level
4

Dyspnea and leg discomfort sensation after 7 days at sea level

Difference/change in dyspnea and leg discomfort sensation (assessed with BORG-CR10-Scale, Category Rating 0-10 with 10 being the most dyspnea/leg discomfort) at rest and end-exercise between 2850m and 5-7 days at sea level in patients with pulmonary arterial hypertension

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Silvia Ulrich Somaini

Lead sponsor

University of Zurich

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: