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Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension (EARLIER)

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ClinicalTrials.gov Identifier: NCT03388476
Recruitment Status : Active, not recruiting
First Posted : January 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Sophie Herbst, University of Giessen

Brief Summary:
Measurement of the endtidal carbon dioxide by capnography to exclude or to ensure the diagnosis pulmonary hypertension. The aim of the study is to obtain an endtidal carbon dioxide cut-off value for the diagnostic algorithm for pulmonary hypertension as an easily measurable and cheap diagnostic tool in patients with suspicion of pulmonary hypertension.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Hypertension;Pulmonary;Primary Chronic Thromboembolic Pulmonary Hypertension Vascular Diseases Lung Diseases Diagnostic Test: Capnography Not Applicable

Detailed Description:

The disease pulmonary hypertension is due to a remodeling of the lung vessels which results in a change of the exhaled air. This change is measurable with a so called capnograph. The investigators want to measure the breath from patients with and without pulmonary hypertension to detect a cut-off value for the diagnosis pulmonary hypertension.

Patients which have the probably diagnosis pulmonary hypertension and are older than 18 years are investigated. This patients will get an right heart catheterization and a measurement from their exhaled air.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension in Patients With Suspicion of Pulmonary Hypertension
Actual Study Start Date : May 2, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021


Arm Intervention/treatment
Suspicion of pulmonary hypertension
At Patients with suspicion of pulmonary hypertension, which get a right heart catheterization, in the context of the study the exhaled air, precious the endtidal carbon dioxide (CO2), before or after the right heart catheterization will be measured through capnography.
Diagnostic Test: Capnography
Measuring of the exhaled air, especially endtidal co2, through capnography.




Primary Outcome Measures :
  1. Measurement PetCO2 [ Time Frame: At baseline ]
    Measurement PetCO2 by capnography at rest after or before a right heart catheterization, comparison of the parameter between patients with and without


Secondary Outcome Measures :
  1. Establishing a cut-off [ Time Frame: At baseline ]
    Establishing a cut-off for the non-invasive diagnosing of pulmonary hypertension, which differs between patients with and without pulmonary hypertension and save patients without the disease before a dispensable invasive right heart catheterization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Age > 18 years, suspicion of pulmonary hypertension, planned or accomplished right heart catheterization

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388476


Locations
Germany
University Clinic Giessen and Marburg
Giessen, Hessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Investigators
Principal Investigator: Henning Gall, MD, PhD University Clinic Giessen and Marburg - Campus Giessen, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine
Study Director: Werner Seeger, Prof. University Clinic Giessen and Marburg - Campus Giessen, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine
Study Director: Ardeschir Ghofrani, Prof. University Clinic Giessen and Marburg - Campus Giessen, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine

Publications:
Responsible Party: Sophie Herbst, Study Chair: Ghofrani H. Ardeschir, Prof. Dr. University of Giessen, University of Giessen
ClinicalTrials.gov Identifier: NCT03388476     History of Changes
Other Study ID Numbers: AZ 156/17
DRKS00013589 ( Registry Identifier: DRKS )
AZ 156/17 ( Other Identifier: Ethik-Kommission Giessen )
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sophie Herbst, University of Giessen:
pulmonary hypertension
endtidal co2
endtidal carbon dioxide
pulmonary arterial hypertension

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