NCT07804524

Brief Summary

To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in patients with pulmonary arterial hypertension PAH, who live permanently \>2600m.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

August 17, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

September 25, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 4, 2026

Status Verified

August 1, 2026

Enrollment Period

9 days

First QC Date

August 17, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

Pulmonary Arterial Hypertension (PAH)HypoxiaHigh AltitudePulmonary HypertensionPulmonary ResistancePulmonary vascular diseaseEchocardiographyhemodynamics

Outcome Measures

Primary Outcomes (1)

  • Pulmonary resistance (sPAP/CO) after 7 days at sea level

    Difference in sPAP/CO by echocardiography 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 (21)

  • Tricuspid regurgitation velocity TRV after 7 days at sea level

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

  • Cardiac output CO after 7 days at sea level

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

  • Tricuspid annular plan systolic excursion TAPSE after 7 days at sea level

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

  • Right ventricular strain after 7 days at sea level

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

  • Right atrial pressure RAP after 7 days at sea level

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

  • +16 more secondary outcomes

Study Arms (1)

Pulmonary resistance (sPAP/CO) at 2850m and at sea level

EXPERIMENTAL

Measurement of pulmonary resistance (sPAP/CO) by echocardiography and other hemodynamic parameters 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 measurements by echocardiography

Behavioral: Descent from 2850m to sea level

Interventions

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

Pulmonary resistance (sPAP/CO) at 2850m and at sea level

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 2850m 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Arterial HypertensionAltitude SicknessHypoxiaHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHypertensionVascular DiseasesCardiovascular 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

Michael Furian, Prof. Dr. sc. ETH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Patients diagnosed with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m and after relocation to sea level
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

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

Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

Locations