COPDNCT00614900
Prevalence of Pulmonary Hypertension in COPD Patients
An observational study of COPD and Pulmonary Hypertension, run by University of Aarhus at 1 site in Denmark.
Trial summary
The prevalence of an increased pulmonary blood pressure amongst patients with chronic obstructive pulmonary disease (COPD)is unclear. So is the impact of abnormal pulmonary blood pressure on symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD, Pulmonary Hypertension
- How many people
- 117 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2008to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients have been admitted to hospital with an exacerbation in COPD in 2006.
Who may be able to join
- Diagnosis of COPD
- Prior admittance to hospital with exacerbation in COPD
- Informed consent
Who cannot join
- Exacerbation in COPD less than 6 weeks before examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Influence of Pulmonary Hypertension in COPD Patients
The prevalence of an increased pulmonary blood pressure amongst patients with chronic obstructive pulmonary disease (COPD)is unclear. So is the impact of abnormal pulmonary blood pressure on symptoms. The aim of this study is to determine the prevalence of an increased pulmonary blood pressure in 200 patients with COPD. Furthermore we will investigate if lung function test results and blood tests can predict an increased pulmonary blood pressure, and explore whether COPD patients with a high pulmonary blood pressure have more symptoms that their co-patients.
Read the detailed description
The prevalence of pulmonary hypertension in patients with chronic obstructive pulmonary disease (COPD) is unclear. The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of COPD, but the patients are not currently diagnosed or treated for pulmonary hypertension. The aim of this study is to determine the prevalence of pulmonary hypertension in 200 patients with COPD and explore whether it worsens functional capacity and symptoms. Furthermore we will look into whether blood gas values, NT-proBNP, CRP and lung function test result can predict which patients are at risk of having pulmonary hypertension.
Methods: All patients will be screened by echocardiography. Those with signs of pulmonary hypertension will be admitted to right heart catheterization for direct measurements of pulmonary haemodynamics.
All patients will perform a 6 minutes walk test and spirometry. Blood levels of NT-proBNP and CRP will be measured. Life quality by the St. George Questionnaire and contacts to the health care system is also assessed. Differences in these parameters are analyzed among patients with no, moderate or severe pulmonary hypertension.
- Conditions
- COPD, Pulmonary Hypertension
- Keywords
- COPD, pulmonary hypertension, NT-proBNP, 6 minutes walk test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startMar 2008
- 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 COPDStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Charlotte Andersen, University of Aarhus
- Investigators
- Ole Hilberg, Md, Dr.med., Study director, Aarhus Universitetshospital, Aarhus Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614900
- Sponsor's protocol ID
- PreKPH-08
- Other IDs
- jnr 2007-0206
- Status last verified
- Sep 2012
- First submitted
- 31 Jan 2008
- 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
- Prevalence and Influence of Pulmonary Hypertension in COPD Patients
- ClinicalTrials.gov ID
- NCT00614900
- Acronym / sponsor ID
- PreKPH-08
- Conditions
- COPD, Pulmonary Hypertension
- Keywords
- COPD, pulmonary hypertension, NT-proBNP, 6 minutes walk test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Feb 2008 (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 prevalence of an increased pulmonary blood pressure amongst patients with chronic obstructive pulmonary disease (COPD)is unclear. So is the impact of abnormal pulmonary blood pressure on symptoms. The aim of this study is to determine the prevalence of an increased pulmonary blood pressure in 200 patients with COPD. Furthermore we will investigate if lung function test results and blood tests can predict an increased pulmonary blood pressure, and explore whether COPD patients with a high pulmonary blood pressure have more symptoms that their co-patients.
Detailed description
The prevalence of pulmonary hypertension in patients with chronic obstructive pulmonary disease (COPD) is unclear. The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of COPD, but the patients are not currently diagnosed or treated for pulmonary hypertension. The aim of this study is to determine the prevalence of pulmonary hypertension in 200 patients with COPD and explore whether it worsens functional capacity and symptoms. Furthermore we will look into whether blood gas values, NT-proBNP, CRP and lung function test result can predict which patients are at risk of having pulmonary hypertension.
Methods: All patients will be screened by echocardiography. Those with signs of pulmonary hypertension will be admitted to right heart catheterization for direct measurements of pulmonary haemodynamics.
All patients will perform a 6 minutes walk test and spirometry. Blood levels of NT-proBNP and CRP will be measured. Life quality by the St. George Questionnaire and contacts to the health care system is also assessed. Differences in these parameters are analyzed among patients with no, moderate or severe pulmonary hypertension.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients have been admitted to hospital with an exacerbation in COPD in 2006.
Key inclusion criteria (3 listed)
- Diagnosis of COPD
- Prior admittance to hospital with exacerbation in COPD
- Informed consent
Key exclusion criteria (1 listed)
- Exacerbation in COPD less than 6 weeks before examination
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.
Ole Hilberg, Md, Dr.med. study director
Aarhus Universitetshospital, Aarhus Sygehus
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 COPD and Pulmonary Hypertension, run by University of Aarhus at 1 site 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 3 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: 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 1 site 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.