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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension in Patients With Suspicion of Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03388476
- Acronym / sponsor ID
- EARLIER / AZ 156/17
- Conditions
- Hypertension, Pulmonary, Hypertension;Pulmonary;Primary, Chronic Thromboembolic Pulmonary Hypertension, Vascular Diseases, Lung Diseases
- Keywords
- pulmonary hypertension, endtidal co2, endtidal carbon dioxide, pulmonary arterial hypertension
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicion of pulmonary hypertension | – | Diagnostic Test: CapnographyAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Age > 18 years, suspicion of pulmonary hypertension, planned or accomplished right heart catheterization
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapnographyMeasuring of the exhaled air, especially endtidal co2, through capnography. | Diagnostic test | Suspicion of pulmonary hypertension |
Primary outcome
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
1 secondary outcome
Establishing a cut-off
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 21622547Hemnes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henning Gall, MD, PhD principal investigator
University Clinic Giessen and Marburg - Campus Giessen
Werner Seeger, Prof. study director
University Clinic Giessen and Marburg
Ardeschir Ghofrani, Prof. study director
University Clinic Giessen and Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary and Hypertension;Pulmonary;Primary, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement PetCO2 (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.