NAFLD/MAFLDNCT05239260
Impact of Fluid Status on Liver Elastography and T1-mapping Results in Patients Undergoing CMR.
An observational study of NAFLD/MAFLD and Liver Fibrosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Correlation between CMR T1-times, liver T1-times, fibroscan and fluid status to identify the correlation and pathogenesis of liver disease in patients with heart disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- NAFLD/MAFLD, Liver Fibrosis, CMR
- What is being tested?
- CMR
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2022to 1 Jan 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All-comer cohort referred for Cardiovascular Magnetic Resonance Imaging
Who may be able to join
- Referred for Cardiovascular Magnetic Resonance Imaging
Who cannot join
- Non-compatible Devices
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna, 1090
Andreas Kammerlander, 0043 1 4040048595, andreas.kammerlander@meduniwien.ac.at
About this study
Correlation between CMR T1-times, liver T1-times, fibroscan and fluid status to identify the correlation and pathogenesis of liver disease in patients with heart disease.
- Conditions
- NAFLD/MAFLD, Liver Fibrosis, CMR
- Being tested
- CMR
- Keywords
- NAFLD, CMR
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMRDiagnostic test
Also called Fibroscan, Body composition monitor
CMR
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of fluid status on liver elastography and T1-times
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Feb 2022
- Primary completion1 May 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD/MAFLDStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andreas Kammerlander, Medical University of Vienna
- Investigators
- Andreas Kammerlander, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239260
- Sponsor's protocol ID
- Liver-T1-CMR-2575
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fluid Status on Liver Elastography and T1-mapping Results in Patients Undergoing CMR.
- ClinicalTrials.gov ID
- NCT05239260
- Acronym / sponsor ID
- Liver-T1-CMR-2575
- Conditions
- NAFLD/MAFLD, Liver Fibrosis, CMR
- Keywords
- NAFLD, CMR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 14 Feb 2022 (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.
Correlation between CMR T1-times, liver T1-times, fibroscan and fluid status to identify the correlation and pathogenesis of liver disease in patients with heart disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All-comer cohort referred for Cardiovascular Magnetic Resonance Imaging
Key inclusion criteria (1 listed)
- Referred for Cardiovascular Magnetic Resonance Imaging
Key exclusion criteria (1 listed)
- Non-compatible Devices
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 |
|---|---|---|
| CMRAlso: Fibroscan, Body composition monitorCMR | Diagnostic test | – |
Primary outcome
Impact of fluid status on liver elastography and T1-times
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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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.
Andreas Kammerlander principal investigator
Medical University of Vienna
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 NAFLD/MAFLD and Liver Fibrosis, run by Medical University of Vienna at 1 site in Austria.
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: status not confirmed, as of the sponsor's last update on 14 Feb 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katharina Mascherbauer (0043 1 40400 48590, katharina.mascherbauer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of fluid status on liver elastography and T1-times (time frame: 5 months). It is what the study was designed to measure, not a finding.
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 14 Feb 2022.