CirrhosisNCT00250315
DOCICAR: Cardiac Dysfunction in Cirrhosis
An observational study of Cirrhosis and Cirrhotic Cardiomyopathy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Patients with cirrhosis have a altered cardiac response to stress. This study evaluate the cardiac response by MRI during dobutamine stress. Hypothesis: impared increase in cardiac output, cardiac index, ejection fraction. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Cirrhotic Cardiomyopathy
- What is being tested?
- Dobutamine
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to Oct 2007
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non alkoholic cirrhosis
Who cannot join
- Coma hepaticum
- Primary cardiac diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Dysfunction in Cirrhosis: Cirrhotic Cardiomyopathy Evaluated by Dobutamin MRI.
Patients with cirrhosis have a altered cardiac response to stress. This study evaluate the cardiac response by MRI during dobutamine stress. Hypothesis: impared increase in cardiac output, cardiac index, ejection fraction.
- Conditions
- Cirrhosis, Cirrhotic Cardiomyopathy
- Being tested
- Dobutamine
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startNov 2005
- Study completionOct 2007
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 CirrhosisStudies 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Søren Møller, DrMsci, MD, Study director, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250315
- Sponsor's protocol ID
- (KF) 01 270675
- Status last verified
- Oct 2007
- First submitted
- 4 Nov 2005
- Last updated
- 1 Nov 2007
- Results posted
- No
Publications
Dahl EK, Moller S, Kjaer A, Petersen CL, Bendtsen F, Krag A. Diastolic and autonomic dysfunction in early cirrhosis: a dobutamine stress study. Scand J Gastroenterol. 2014 Mar;49(3):362-72. doi: 10.3109/00365521.2013.867359. Epub 2013 Dec 16.
PubMed 24329122
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Dysfunction in Cirrhosis: Cirrhotic Cardiomyopathy Evaluated by Dobutamin MRI.
- ClinicalTrials.gov ID
- NCT00250315
- Acronym / sponsor ID
- (KF) 01 270675
- Conditions
- Cirrhosis, Cirrhotic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 8 Nov 2005 (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.
Patients with cirrhosis have a altered cardiac response to stress. This study evaluate the cardiac response by MRI during dobutamine stress. Hypothesis: impared increase in cardiac output, cardiac index, ejection fraction.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non alkoholic cirrhosis
Key exclusion criteria (2 listed)
- Coma hepaticum
- Primary cardiac diseases
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 |
|---|---|---|
| Dobutamine | Drug | – |
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 1 Nov 2007.
- Derived from this study: PubMed 24329122Dahl EK, Moller S, Kjaer A, Petersen CL, Bendtsen F, Krag A. Diastolic and autonomic dysfunction in early cirrhosis: a dobutamine stress study. Scand J Gastroenterol. 2014 Mar;49(3):362-72. doi: 10.3109/00365521.2013.867359. Epub 2013 Dec 16.
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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.
Søren Møller, DrMsci, MD study director
Hvidovre University Hospital
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 Cirrhosis and Cirrhotic Cardiomyopathy, run by Hvidovre University Hospital 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 1 inclusion and 2 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 1 Nov 2007. 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?
On the ClinicalTrials.gov record for NCT00250315, 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 1 Nov 2007.