Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 3 of 20 for:    Pegasus

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by University of Giessen
Sponsor:
Collaborators:
Universitätsklinikum Hamburg-Eppendorf
DRK Kliniken Berlin Köpenick, Berlin, Germany
University Hospital, Zürich
University Hospital Carl Gustav Carus
Information provided by (Responsible Party):
Jan Grimminger, University of Giessen
ClinicalTrials.gov Identifier:
NCT03051763
First received: February 1, 2017
Last updated: February 16, 2017
Last verified: February 2017
  Purpose

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.

Condition
Pulmonary Hypertension
Pulmonary Arterial Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PEGASUS - The Effects of Commercial Air Travel on Patients Suffering From Pulmonary Hypertension: A Prospective, Multicentric Analysis

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Patient questionnaire [ Time Frame: 2 years ]
    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).


Secondary Outcome Measures:
  • Defining possible predictive parameters for patient in flight safety [ Time Frame: 2 years ]
    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.

  • Defining possible predictive parameters for patient in flight safety in echocardiography [ Time Frame: 2 years ]
    Assessment of TAPSE in mm as well as Tei-Index

  • Defining possible predictive parameters for patient in flight safety in hemodynamics [ Time Frame: 2 years ]
    Assessment of mPAP in mmHg, PVR in WU as well as CI in l/min/m2

  • Defining possible predictive parameters for patient in flight safety in spiroergometry [ Time Frame: 2 years ]
    Assessment of VO2max in ml/kg*min

  • Defining possible predictive parameters for patient in flight safety in six minute walk test [ Time Frame: 2 years ]
    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


Estimated Enrollment: 1000
Actual Study Start Date: January 19, 2017
Estimated Study Completion Date: May 19, 2019
Estimated Primary Completion Date: January 19, 2019 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Study Population
Patients diagnosed with pulmonary (arterial) hypertension planing commercial air travel.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • missing written and informed consent
  • cystic fibrosis
  • significant left cardiac impairment
  • LVEF < 45%
  • history of atrial flutter
  • aortic / mitral valve vitium > mild
  • history of myocardial infarction
  • coronary bypass
  • clinically significant anemia (Hb < 8,0g/l).
  • malignoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03051763

Contacts
Contact: Jan Grimminger, MD +491522816696 j.grimminger@uke.de
Contact: Henning Gall, PhD +4964198556766 henning.gall@innere.med.uni-giessen.de

Locations
Germany
University Clinic Giessen and Marburg Recruiting
Giessen, Hesse, Germany, 35392
Contact: Heuser Sina    +4964198557043    pegasusstudy@gmx.net   
Contact: Henning Gall, PhD    +4964198556766    pegasusstudy@gmx.net   
Principal Investigator: Ardeschir Ghofrani, Prof.         
Sub-Investigator: Manuel Richter, MD         
Sub-Investigator: Natascha Sommer, PhD         
Sub-Investigator: Henning Gall, PhD         
Sub-Investigator: Khodr Tello, MD         
Sub-Investigator: Jan Grimminger, MD         
University Clinic Dresden Not yet recruiting
Dresden, Sachsen, Germany, 01307
Contact: Michael Halank, Prof.       pegasusstudy@gmx.net   
DRK Kliniken Berlin Not yet recruiting
Berlin, Germany, 14050
Contact: Christian Opitz, Prof.       pegasusstudy@gmx.net   
University Clinic Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Jan Grimminger, MD    +4915222816696    pegasusstudy@gmx.net   
Contact: Anja Paulsen    +4940741057395    pegasusstudy@gmx.net   
Principal Investigator: Jan Grimminger, MD         
Sub-Investigator: Hans Klose, PhD         
Sub-Investigator: Tim Oqueka, MD         
Sub-Investigator: Sören Galow, MD         
Sub-Investigator: Marcel Simon, MD         
Sub-Investigator: Jan Hennigs, MD         
Sub-Investigator: Anna Nolde, MD         
Sub-Investigator: Lars Harbaum, MD         
Switzerland
Universitätsspital Zürich Not yet recruiting
Zürich, Zurich, Switzerland, 8091
Contact: Silvia Ulrich, Prof.       pegasusstudy@gmx.net   
Sponsors and Collaborators
University of Giessen
Universitätsklinikum Hamburg-Eppendorf
DRK Kliniken Berlin Köpenick, Berlin, Germany
University Hospital, Zürich
University Hospital Carl Gustav Carus
Investigators
Study Chair: Ghofrani H. Ardeschir, Prof. Dr. University of Giessen
  More Information

Responsible Party: Jan Grimminger, MD, University of Giessen
ClinicalTrials.gov Identifier: NCT03051763     History of Changes
Other Study ID Numbers: 204/16
Study First Received: February 1, 2017
Last Updated: February 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Giessen:
pulmonary hypertension
commercial air travel

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 27, 2017