Hypertension, PulmonaryEARLIERNCT03388476
Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension
An observational study of Hypertension, Pulmonary and Hypertension;Pulmonary;Primary, run by University of Giessen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pulmonary, Hypertension;Pulmonary;Primary, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Capnography
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2018to 1 Jan 2035
- Phase
- Observational
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of a tertiary referral center retro- and prospective part of the study. Afterwards in a next prospective study part patients in ambulant setting.
Who may be able to join
- Age > 18 years, suspicion of pulmonary hypertension, planned or accomplished right heart catheterization
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension in Patients With Suspicion of Pulmonary Hypertension
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.
Read the 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.
- Conditions
- Hypertension, Pulmonary, Hypertension;Pulmonary;Primary, Chronic Thromboembolic Pulmonary Hypertension, Vascular Diseases, Lung Diseases
- Being tested
- Capnography
- Keywords
- pulmonary hypertension, endtidal co2, endtidal carbon dioxide, pulmonary arterial hypertension
- Medical subject headings
- Hypertension, Pulmonary, Familial Primary Pulmonary Hypertension, Vascular Diseases, Lung Diseases, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapnographyDiagnostic test
Measuring of the exhaled air, especially endtidal co2, through capnography.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement PetCO2
Measurement PetCO2 by capnography at rest after or before a right heart catheterization, comparison of the parameter between patients with and without
Measured: At baseline
Secondary outcomes (1)
Establishing a cut-off
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start2 May 2018
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Herbst, University of Giessen
- Investigators
- Henning Gall, MD, PhD, Principal investigator, University Clinic Giessen and Marburg - Campus GiessenWerner Seeger, Prof., Study director, University Clinic Giessen and MarburgArdeschir Ghofrani, Prof., Study director, University Clinic Giessen and Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388476
- Sponsor's protocol ID
- AZ 156/17
- Other IDs
- DRKS00013589, AZ 156/17
- Acronym
- EARLIER
- Status last verified
- May 2022
- First submitted
- 22 Dec 2017
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hemnes AR, Pugh ME, Newman AL, Robbins IM, Tolle J, Austin ED, Newman JH. End tidal CO(2) tension: pulmonary arterial hypertension vs pulmonary venous hypertension and response to treatment. Chest. 2011 Nov;140(5):1267-1273. doi: 10.1378/chest.11-0155. Epub 2011 May 26.
PubMed 21622547