Altitude Related Adverse Health Effects (ARAHE) in Patients With Precapillary Pulmonary Hypertension During 30h Exposure to 2500m

NCT05107700 | Completed

• 1 other identifier: OVERALP II A
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The interest of journeys to high altitude regions for recreational or professional purposes is increasing, also among potentially vulnerable groups including patients with chronic cardiopulmonary diseases such as pulmonary hypertension (PH). In Switzerland and many other regions worldwide, many settlements and alpine resorts are at altitudes above 1500m and alpine tourism is an important social and economic sector. However, the hypoxic environment at altitude may induce altitude related adverse health effects (ARAHE), including hypoxemia, symptoms of acute mountain sickness (AMS), reduces exercise capacity and increases the pulmonary arterial pressure, which is of particular relevance for patients with chronic hypoxemic respiratory diseases including PH. On the other hand, advances in disease-targeted medical combination therapies renders PH to the chronic disease groups with many patients surviving for many years with a relatively good quality of live, exercise capacity and low symptom burden. However, data on ARAHE and the exercise capacity of patients with pre-existing PH at altitude is scarce, so that current expert-based guidelines discourage altitude travel for patients with PH. However, we previously showed that the majority of stable PH-patients tolerates normobaric hypoxia or a short trip to 2500m well. With this project we aim to get profound clinical and pathophysiological insights into the effects of the hypobaric hypoxic environment at altitude during an overnight stay up to 30 hours on the incidence of ARAHE needing oxygen therapy, exercise capacity, pulmonary hemodynamics and sleep in patients with precapillary PH. We hope that this new valuable data will provide a basis to better counsel PH-patients for potential risk of altitude sojourns.

Conditions

High Altitude Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Incidence of altitude-related adverse health effects (ARAHE as defined below) during a sojourn at 2500m, time frame up to 30 h. ARAHE will be defined by any of the following criteria:

  * Acute mountain sickness with a Lake Louise score \>4 including headache, or AMSc score ≥0.7 * severe hypoxemia defined as: resting SpO2 \<75% for \>15 min or \<80% for \>30 min; exercise SpO2 \<75% for \>5 min and/or criteria for stopping exercise according to guidelines * intercurrent illness: infection, neurologic, impairment, other new diseases/accidents, requiring medical treatment other than simple measures such as paracetamol * chest pain and/or ECG signs of cardiac ischemia, syncope, tachy- or bradyarrhythmia, severe hyper- or hypotension accompanied by symptoms * dyspnoea at rest and/or any discomfort requiring treatment and/or leading to the wish of a patient to return to low altitude or withdraw from the study

  30 hours

Secondary Outcomes (9)

• Components of altitude-related adverse health effects

  30 hours

• Severity of symptoms

  30 hours

• Difference in pulmonary artery pressure

  30 hours

• Difference in pulmonary vascular resistance assessed

  30 hours

• Difference in right ventricular function

  30 hours

Study Arms (2)

Start with: Stay at altitude 2500 m above sea level (high altitude)

EXPERIMENTAL

Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 2500 m.

Procedure: Stay at altitude 2500 m above sea level (high altitude); Procedure: Stay at altitude 470 m above sea level (low altitude)

Start with: Stay at altitude 470 m above sea level (low altitude)

PLACEBO COMPARATOR

Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 470 m as comparator.

Procedure: Stay at altitude 2500 m above sea level (high altitude); Procedure: Stay at altitude 470 m above sea level (low altitude)

Interventions

Stay at altitude 2500 m above sea level (high altitude) PROCEDURE

Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 2500 m.

Start with: Stay at altitude 2500 m above sea level (high altitude); Start with: Stay at altitude 470 m above sea level (low altitude)

Stay at altitude 470 m above sea level (low altitude) PROCEDURE

Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 470 m.

Start with: Stay at altitude 2500 m above sea level (high altitude); Start with: Stay at altitude 470 m above sea level (low altitude)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent as documented by signature
• PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

You may not qualify if:

• Resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
• Exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
• Inability to follow the procedures of the study
• Other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Muller J, Mayer L, Schneider SR, Bauer M, Furian M, Bloch KE, Schwarz EI, Lichtblau M, Silvia U. Pulmonary haemodynamics and right heart function during exercise at high versus low altitude in patients with pulmonary vascular disease: a randomised crossover trial. Heart. 2025 Dec 11;112(1):28-36. doi: 10.1136/heartjnl-2024-325605.

  PMID: 40404280 DERIVED

MeSH Terms

Conditions

Pulmonary edema of mountaineers

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 4, 2021
• Study Start: October 18, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

CH (1)