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Assessment of Heart Rate Variability HRV During Descent DE From 2850m to Sea Level and During Re-ascent A From Sea Level to 2850m in Patients With Pulmonary Arterial Hypertension PAH

ConditionsHigh Altitude EffectsHigh AltitudePulmonary Vascular DiseasePulmonary Arterial Hypertension (PAH)Heart Rate Variability (HRV)ECG Abnormalities
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 Ecuador: 2850m) to sea level and re-ascent from sea level to 2850m on heart rate variability and other hemodynamic parameters 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 and re-ascent (2850m, sea level)

    Behavioral

    Descent from 2850m to sea level (in one day by bus) and re-ascent after 7 days from sea level to 2850m (in one day by bus)

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Heart rate variability HRV during descent and re-ascentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Heart rate variability HRV during descent and re-ascent

Difference/change in heart rate variability at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension

Time frame
From day of descent (day 1) and day of re-ascent (day 8)

Secondary outcomes

1

SpO2 during descent and re-ascent

Difference/change in SpO2 at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension

Time frame
From day of descent (day 1) and day of re-ascent (day 8)
2

ECG-Repolarization during descent and re-ascent

Difference/change in ECG-repolarization at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension

Time frame
From day of descent (day 1) and day of re-ascent (day 8)
3

Cardial arrhythmias during descent and re-ascent

Occurrence/changes in cardial arrhythmias at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension

Time frame
From day of descent (day 1) and day of re-ascent (day 8)
4

Pulse transit time during descent and re-ascent

Occurrence and difference/change in pulse transit time (drops) at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension

Time frame
From day of descent (day 1) and day of re-ascent (day 8)

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

Source ClinicalTrials.gov

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