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Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH

ConditionsPulmonary Arterial Hypertension (PAH)Pulmonary Vascular DiseaseHigh AltitudeEchocardiographyPulmonary Resistance
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSilvia Ulrich Somaini

About this trial

To study the effect of a re-ascent after a one-week stay at sea level (after prior descent from 2850m) to high altitude (Quito Ecuador: 2850m) on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes 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

  • Re-Ascent from sea level to 2850m

    Behavioral

    After 7 days at sea level return/re-ascent to their usual living altitude at 2850m

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Pulmonary resistance (sPAP/CO) at sea level and after re-ascent at 2850mExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pulmonary resistance (sPAP/CO) after re-ascent to 2850m

Difference in sPAP/CO by echocardiography between sea level (after one-week stay) and day after re-ascent at 2850m in patients with pulmonary arterial hypertension

Time frame
From Day 5-7 at sea level to day after re-ascent

Secondary outcomes

1

Tricuspid regurgitation velocity TRV after re-ascent to 2850m

Difference/change in tricuspid regurgitation velocity TRV between sea level (after one-week stay) and day after re-ascent at 2850m in patients with pulmonary arterial hypertension

Time frame
From Day 5-7 at sea level to day after re-ascent
2

Cardiac output CO after re-ascent to 2850m

Difference/change in cardiac output CO between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension

Time frame
From Day 5-7 at sea level to the day after re-ascent
3

Tricuspid annular plan systolic excursion TAPSE after re-ascent to 2850m

Difference/change in tricuspid annular plan systolic excursion TAPSE between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension

Time frame
From Day 5-7 at sea level to day after re-ascent
4

Right ventricular strain after re-ascent to 2850m

Difference/change in right ventricular strain between sea level (after one-week stay) and Day after re-ascent to 2850m in patients with pulmonary arterial hypertension

Time frame
From Day 5-7 at sea level to day after re-ascent

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: