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

NCT07801859 | Not Yet Recruiting

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

Brief Summary

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.

Conditions

High Altitude Effects; High Altitude; Pulmonary Vascular Disease; Pulmonary Arterial Hypertension (PAH); Heart Rate Variability (HRV); ECG Abnormalities

Keywords

Pulmonary hypertension; Pulmonary arterial hypertension PAH; Pulmonary vascular disease; High altitude; Heart rate variability; ECG; Arrythmias; Pulse transit time

Outcome Measures

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

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

Secondary Outcomes (4)

• SpO2 during descent and re-ascent

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

• ECG-Repolarization during descent and re-ascent

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

• Cardial arrhythmias during descent and re-ascent

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

• Pulse transit time during descent and re-ascent

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

Study Arms (1)

Heart rate variability HRV during descent and re-ascent

EXPERIMENTAL

Assessment of heart rate variability and other hemodynamic outcomes in patients with pulmonary arterial disease during descent from 2850m to sea level and during re-ascent from sea level (after one week stay) back near their living altitude at 2850m

Behavioral: Descent and re-ascent (2850m, sea level)

Interventions

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)

Heart rate variability HRV during descent and re-ascent

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 pulseoximetry) \<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

Altitude Sickness; Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; 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 with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed during descent from 2850m to sea level and during re-ascent after one week from sea level to 2850m

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 3, 2026
• Study Start: September 25, 2026
• Primary Completion: October 4, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)