Interstitial Lung DiseaseNCT00820729
Biomarkers in Pulmonary Hypertension Associated to Interstitial Lung Disease
An observational study of Interstitial Lung Disease and Pulmonary Hypertension, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of patients with interstitial pulmonary disease. The aim of this study is to estimate the frequency of an increased blood pressure in the lungs among patient with interstitial pulmonary disease, and to evaluate the use of different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Pulmonary Hypertension, Biomarkers
- How many people
- 212 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Out-patients with interstitial pulmonary disease.
Who may be able to join
- Interstitial pulmonary disease
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Pulmonary Diseases, Århus Sygehus
Aarhus, Dk-8000
Department of Cardiology, Skejby sygehus
Århus N, DK-8200
About this study
Official title: The Prevalence of Pulmonary Hypertension and the Significance of Different Biomarkers in Chronic Interstitial Lung Disease
The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of patients with interstitial pulmonary disease.
The aim of this study is to estimate the frequency of an increased blood pressure in the lungs among patient with interstitial pulmonary disease, and to evaluate the use of different biomarkers in diagnosis of the condition.
Read the detailed description
The presence of increased pulmonary blood pressure is established by echocardiography and confirmed by right heart catheterization.
The ability of NT-proBNP, vWf, troponin-t, D-dimer and exhaled NO to predict the presence of increased pressure in the pulmonary circulation is evaluated.
- Keywords
- interstitial lung disease, pulmonary hypertension, biomarkers, NT-pro-BNP, von Willebrand factor, D-dimer, Exhaled NO, Troponin-t
- Medical subject headings
- Lung Diseases, Interstitial, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with interstitial pulmonary disease |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Andersen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820729
- Sponsor's protocol ID
- Fibrosis-ECHO 2009
- Status last verified
- Sep 2012
- First submitted
- 9 Jan 2009
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Pulmonary Hypertension and the Significance of Different Biomarkers in Chronic Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT00820729
- Acronym / sponsor ID
- Fibrosis-ECHO 2009
- Keywords
- interstitial lung disease, pulmonary hypertension, biomarkers, NT-pro-BNP, von Willebrand factor, D-dimer, Exhaled NO, Troponin-t
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Jan 2009 (estimated)
- 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.
The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of patients with interstitial pulmonary disease.
The aim of this study is to estimate the frequency of an increased blood pressure in the lungs among patient with interstitial pulmonary disease, and to evaluate the use of different biomarkers in diagnosis of the condition.
Detailed description
The presence of increased pulmonary blood pressure is established by echocardiography and confirmed by right heart catheterization.
The ability of NT-proBNP, vWf, troponin-t, D-dimer and exhaled NO to predict the presence of increased pressure in the pulmonary circulation is evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with interstitial pulmonary disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out-patients with interstitial pulmonary disease.
Key inclusion criteria (1 listed)
- Interstitial pulmonary disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Pulmonary Hypertension, run by University of Aarhus at 2 sites in Denmark.
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 0 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: finished, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 18 Sep 2012.