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

NCT03051763 | Unknown DMC

• 1 other identifier: 204/16
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 5

Brief 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, 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. 1.In which subgroup (if applicable) of PH patients in flight adverse events are more frequent.
2. 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.

Conditions

Pulmonary Hypertension; Pulmonary Arterial Hypertension

Keywords

pulmonary hypertension; commercial air travel

Outcome Measures

Primary Outcomes (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).

  2 years

Secondary Outcomes (5)

• Defining possible predictive parameters for patient in flight safety

  2 years

• Defining possible predictive parameters for patient in flight safety in echocardiography

  2 years

• Defining possible predictive parameters for patient in flight safety in hemodynamics

  2 years

• Defining possible predictive parameters for patient in flight safety in spiroergometry

  2 years

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

  2 years

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• DRK Kliniken Berlin Köpenick, Berlin, Germany: collaborator
• University Hospital, Zürich: collaborator
• University Hospital Carl Gustav Carus: collaborator

Study Sites (5)

University Clinic Giessen and Marburg

Giessen, Hesse, 35392, Germany

RECRUITING

University Clinic Dresden

Dresden, Saxony, 01307, Germany

NOT YET RECRUITING

DRK Kliniken Berlin

Berlin, 14050, Germany

NOT YET RECRUITING

University Clinic Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Universitätsspital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ghofrani H. Ardeschir, Prof. Dr.

  University of Giessen

  STUDY CHAIR

Central Study Contacts

Jan Grimminger, MD

CONTACT

+491522816696; j.grimminger@uke.de

Henning Gall, PhD

CONTACT

+4964198556766; henning.gall@innere.med.uni-giessen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 14, 2017
• Study Start: January 19, 2017
• Primary Completion: December 19, 2021
• Study Completion: May 19, 2022
• Last Updated: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); CH (1)