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Pulmonary HypertensionPEGASUSNCT03051763

The Effects of Commercial Air Travel on Patients Suffering From Pulmonary Hypertension

An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by University of Giessen at 5 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to 1) descriptively report possible in flight events and 2) to provide regression analysis if the number of events are statistically significant in their prevalence and thus are useful in finding possible parameters in echocardiography, right heart catheterization, laboratory findings… Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,000 participants
Where
5 sitesin 2 countries
Study dates
19 Jan 2017to 19 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with pulmonary (arterial) hypertension planing commercial air travel.

Who may be able to join

  • written an informed consent
  • invasively diagnosed pulmonary hypertension
  • mPAP > 25mmHg
  • PAWP < 15mmHg
  • PVR < 3WU

Who cannot join

  • missing written and informed consent
  • cystic fibrosis
  • significant left cardiac impairment
  • LVEF < 45%
  • history of atrial flutter
  • aortic / mitral valve vitium > mild
Show all 10Show fewer
  • history of myocardial infarction
  • coronary bypass
  • clinically significant anemia (Hb < 8,0g/l).
  • malignoma

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Germany4 sites, 4 recruiting
  • DRK Kliniken Berlin

    Berlin, 14050

    Christian Opitz, Prof., pegasusstudy@gmx.net

    Not yet recruiting
  • University Clinic Dresden

    Dresden, Saxony, 01307

    Michael Halank, Prof., pegasusstudy@gmx.net

    Not yet recruiting
  • University Clinic Giessen and Marburg

    Giessen, Hesse, 35392

    Heuser Sina, +4964198557043, pegasusstudy@gmx.net

    Henning Gall, PhD, +4964198556766, pegasusstudy@gmx.net

    Recruiting
  • University Clinic Hamburg-Eppendorf

    Hamburg, 20246

    Jan Grimminger, MD, +4915222816696, pegasusstudy@gmx.net

    Anja Paulsen, +4940741057395, pegasusstudy@gmx.net

    Recruiting

Other trials in Germany

Switzerland1 site, 1 recruiting
  • Universitätsspital Zürich

    Zurich, Canton of Zurich, 8091

    Silvia Ulrich, Prof., pegasusstudy@gmx.net

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: PEGASUS - The Effects of Commercial Air Travel on Patients Suffering From Pulmonary Hypertension: A Prospective, Multicentric Analysis

The aim of this study is to 1) descriptively report possible in flight events and 2) to provide regression analysis if the number of events are statistically significant in their prevalence and thus are useful in finding possible parameters in echocardiography, right heart catheterization, laboratory findings, spiroergometry as well as six minute walk test to produce a risk assessment for possible expected in flight adverse events as well as a recommendation concerning the need of supplemental oxygen for each individual patient.

The investigators therefore want to find out:

  1. In which subgroup (if applicable) of PH patients in flight adverse events are more frequent.
  2. Whether there are parameters (from blood samples, blood gas analysis, World Health Organization-Functional Class (WHO-FC), Six Minute Walk (SMW), echocardiography, right heart catheter (RHC)) that are able to predict in flight need for additional oxygen and/or possible adverse events.
Read the detailed description

Pulmonary Hypertension (PH) is a progressive disease affecting the pulmonary vessels and leading to an increased pulmonary vascular resistance (PVR) and thus right heart strain. The result is an increase in mean pulmonary arterial pressure (mPAP) and with time dilation of the right heart chambers as well as hypertrophy of the right ventricular myocardium. As the increase in PVR progresses further, the right ventricle struggles to cope with the rising afterload and starts to fail. Before this worst case scenario occurs, most individuals suffering from PH notice dyspnea on exertion as the first sign of their underlying disease. The increased proliferation and the resulting rise in PVR lead to a slower blood flow through the pulmonary vessels and thus sometimes result in in situ thrombosis. Furthermore the thickening of the capillary vessel bed increases the diffusion barrier for oxygen and herby results ventilation-perfusion mismatch and leads to hypoxia first during exercise, and later even at rest, making long term oxygen therapy (LTOT) necessary. Today's specific pulmonary-vasoactive therapy helps individuals suffering from PH to live a "normal" life. For most people this also means going on vacation - if necessary by plane. The latter however bares risks for patients suffering from PH:

While the average traveling altitude of passenger planes is between 9.150 - 12.200m (30.000 - 40.000ft) where the atmospheric pressure is less than 30% compared to that at sea level, reducing the pressure of inspired oxygen (PIO2) from 143mmHg to less than 40mmHg. In other words the air contains less than 6% oxygen compared to 21% at sea level. Since this is not compatible with human life airplane cabins are pressurized to maintain a pressure equally to a height between 1520 - 2440m (5.000 - 8.000ft) which contains about 15% of oxygen. However, even the National Research Council (NRC) stated that passengers with cardiovascular problems might experience discomfort within this cabin environment. These conditions of hypobaric hypoxia, even in the pulmonary vasculature of a healthy individual, lead to a generalized hypoxic pulmonary vasoconstriction (HPV). These changes, in healthy individual lead to a rise in PVR and thus right ventricular systolic pressure (RVSP). Healthy individuals are able to compensate the resulting increase in right ventricular afterload. It however is easily imaginable that the heart of a patient with right heart insufficiency may struggle or even fail under these circumstances. Increasing the PIO2 through supplemental oxygen (O2) is known to prevent these changes, which is why it is recommended to be used by patients with world health organization functional class (WHO-FC) III and IV as well as patients with arterial blood O2 pressure consistently <, 60mmHg (8 kPa) by the current guidelines. This general advice is given by the American Aerospace Medical Association and the British Thoracic Society as well. There is however a problem with most of these recommendations: There's a lack of studies concerning the effects of commercial air travel on patients with PH, which is why many recommendations are made by transferring data from surveys about more common lung diseases. There are however some studies on the effects of (simulated) air travel in patients with PH:

In 2012 a survey was conducted where hypoxic challenge test (HCT) was performed on 36 individuals suffering from PH and compared the acquired data of HCT and WHO-FC with the actual need of in flight oxygen. The latter information was gained through a questionnaire handed out to the before named individuals that focused on in flight symptoms and events that lead to the use of in flight oxygen prior to and after diagnosis of PH. It was found that 25 out of the examined 36 individuals according to the current recommendations would need in flight oxygen judging by their WHO-FC, but only 10 failed HCT. Out of all 36 patients, 14 traveled by plane after being diagnosed with PH. Of these, nine subjects should have had in-flight oxygen based on WHO-FC but were asymptomatic without. Furthermore 1 individual that passed the HCT had developed symptoms during the flight and 3 who failed the HCT were asymptomatic flying without oxygen. In other words: HCT did not identify one patient who developed symptoms during a flight.

In the same year another study was published with data of a prospective survey from 34 individuals of which data was collected during flight. Cabin pressure, peripheral oxygen saturation (SpO2), heart rate and symptoms were assessed. Desaturation was defined as SpO2 < 85%. It was found that nine individuals experienced significant desaturation. Furthermore only five out of the 13 patients that reported symptoms presented desaturation during their flight. Furthermore no predictive factor to predict possible desaturation during the time being airborne (neither resting SpO2 at sea level nor maximal estimated cabin altitude was predictive) were found.

In 2011 a retrospective analysis during which patients with diagnosed PH, who had traveled by airplane, were asked to complete a questionnaire containing general information (group of PH, WHO-FC, current medication, usage of LTOT, etc.) as well as possible symptoms conceived (dyspnea, chest pain, peripheral edema, etc.) was released. Out of 179 patients who had traveled by plane 57 were under LTOT and 29 used supplemental oxygen during the flight. In total 20 adverse events were reported (mainly mild to moderate in severity) and 7 needed medical assistance. In total 159 out of 179 patients didn't experience any discomfort during or shortly after their travel.

In summary of the scarce data available hitherto there is no sufficient test available to predict in flight complications in patients with pulmonary hypertension. It could however be shown that using WHO-FC as the only surrogate is not useful to determine which patient might be in need of additional oxygen during air travel. Furthermore even HCT is not capable of detecting patients at risk. Even the British Thoracic Society marks their recommendations on the use of supplemental oxygen for patients with PH with "evidence level D".

It is this absence of sufficient data and the thereby resulting uncertainty of patients, physicians, pneumologist and cardiologists as well as specialists in the field of PH on this topic that lead to the concept of this study. By this prospective survey on patients suffering from all forms of PH, under all different types of available treatments and in all WHO-FCs the investigators hope to gain further insight in possible markers to predict in flight adverse events and thus make flying safer for individuals struggling with PH. This study therefore aims to include a total of 1000 patients suffering from all forms of PH which, after providing written and informed consent, will be asked to fill out a questionnaire prior to and after air traveling as well as assessing vital parameters (SpO2, pulse and respiration rate) prior to, during and shortly after their flight. In addition all clinical data available will be collected and analyzed. The aim of this study is to find possible parameters in echocardiography, right heart catheterization, laboratory findings, spiroergometry as well as six minute walk test to produce a risk assessment for possible expected in flight adverse events as well as a recommendation concerning the need of supplemental oxygen for each individual patient.

All data collected will be anonymised to prevent possible identification of each participating individual. Examinations conducted during this survey would have been necessary anyway in the course of regular clinical visits. So there will be no additional health risk for patients participating in the study.

Keywords
pulmonary hypertension, commercial air travel
Medical subject headings
Hypertension, Pulmonary, Pulmonary Arterial Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient questionnaire

    Self report of possible (serious) adverse events (desaturation, palpitations, thoracic tightness / pain, dizziness, syncope) during flight by a specific questionnaire. Each symptom may be marked with 1 (occurred) and 0 (did not occur).

    Measured: 2 years

Secondary outcomes (5)
  1. Defining possible predictive parameters for patient in flight safety

    Reported in flight events will lead to further investigations concerning clinically gained data to find possible markers that are useful in predicting which individual is safe to fly, which should not fly at all and which is recommended to use additional oxygen during the flight.

    Measured: 2 years

  2. Defining possible predictive parameters for patient in flight safety in echocardiography

    Assessment of TAPSE in mm as well as Tei-Index

    Measured: 2 years

  3. Defining possible predictive parameters for patient in flight safety in hemodynamics

    Assessment of mPAP in mmHg, PVR in WU as well as CI in l/min/m2

    Measured: 2 years

  4. Defining possible predictive parameters for patient in flight safety in spiroergometry

    Assessment of VO2max in ml/kg*min

    Measured: 2 years

  5. Defining possible predictive parameters for patient in flight safety in six minute walk test

    Assessment of covered distance in m, possible desaturation in %, possible changes in blood pressure in mmHg as well as changes in puls in beats/min

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study start19 Jan 2017
  3. Primary completion19 Dec 2021 (estimated)
  4. Study completion19 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03051763
Sponsor's protocol ID
204/16
Acronym
PEGASUS
Status last verified
Nov 2020
First submitted
1 Feb 2017
Last updated
2 Dec 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by University of Giessen at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jan Grimminger, MD (+491522816696, j.grimminger@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient questionnaire (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.

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