Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension (EARLIER)
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|ClinicalTrials.gov Identifier: NCT03388476|
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2018
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pulmonary Hypertension;Pulmonary;Primary Chronic Thromboembolic Pulmonary Hypertension Vascular Diseases Lung Diseases||Diagnostic Test: Capnography||Not Applicable|
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)|
|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|
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.
- 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
- 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
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
|University Clinic Giessen and Marburg|
|Giessen, Hessen, Germany, 35392|
|Principal Investigator:||Henning Gall, MD, PhD||University Clinic Giessen and Marburg - Campus Giessen|
|Study Director:||Werner Seeger, Prof.||University Clinic Giessen and Marburg|
|Study Director:||Ardeschir Ghofrani, Prof.||University Clinic Giessen and Marburg|