NAFLDNCT04220450
T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease
An observational study of NAFLD and Heart Failure, run by Dr. Andreas Kammerlander at 1 site in Austria.
Trial summary
On clinically indicated Cardiovascular Magnetic Resonance studies, native T1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- NAFLD, Heart Failure, Valvular Disease
- What is being tested?
- T1 mapping on Cardiovascular Magnetic Resonance Studies
- How many people
- 800 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2020to 15 Jun 2021
- 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 months and older
- All sexes
- 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.
About this study
On clinically indicated Cardiovascular Magnetic Resonance studies, native T1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease.
- Conditions
- NAFLD, Heart Failure, Valvular Disease, Coronary Disease
- Being tested
- T1 mapping on Cardiovascular Magnetic Resonance Studies
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Heart Failure, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1 mapping on Cardiovascular Magnetic Resonance StudiesDiagnostic test
On clinically indicated Cardiovascular Magnetic Resonance Imaging Studies, native T1-times and extracellular volume will be determined
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation NAFLD and liver T1mapping
Correlation NAFLD risk score and liver T1-mapping (native and ECV9
Measured: cross-sectional within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion15 Jun 2021 (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 NAFLDStudies 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
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Andreas Kammerlander
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Andreas Kammerlander, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220450
- Sponsor's protocol ID
- NAFLD-CMR-2436
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2020
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mascherbauer K, Dona C, Koschutnik M, Dannenberg V, Nitsche C, Duca F, Heitzinger G, Halavina K, Steinacher E, Kronberger C, Bardach C, Beitzke D, Loewe C, Waldmann E, Trauner M, Barkto P, Goliasch G, Mascherbauer J, Hengstenberg C, Kammerlander A. Hepatic T1-Time Predicts Cardiovascular Risk in All-Comers Referred for Cardiovascular Magnetic Resonance: A Post-Hoc Analysis. Circ Cardiovasc Imaging. 2022 Oct;15(10):e014716. doi: 10.1161/CIRCIMAGING.122.014716. Epub 2022 Oct 18.
PubMed 36256728
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04220450
- Acronym / sponsor ID
- NAFLD-CMR-2436
- Conditions
- NAFLD, Heart Failure, Valvular Disease, Coronary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Dr. Andreas KammerlanderUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 7 Jan 2020 (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.
On clinically indicated Cardiovascular Magnetic Resonance studies, native T1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- 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 |
|---|---|---|
| T1 mapping on Cardiovascular Magnetic Resonance StudiesOn clinically indicated Cardiovascular Magnetic Resonance Imaging Studies, native T1-times and extracellular volume will be determined | Diagnostic test | – |
Primary outcome
Correlation NAFLD and liver T1mapping
Time frame: cross-sectional within one year
Correlation NAFLD risk score and liver T1-mapping (native and ECV9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 36256728Mascherbauer K, Dona C, Koschutnik M, Dannenberg V, Nitsche C, Duca F, Heitzinger G, Halavina K, Steinacher E, Kronberger C, Bardach C, Beitzke D, Loewe C, Waldmann E, Trauner M, Barkto P, Goliasch G, Mascherbauer J, Hengstenberg C, Kammerlander A. Hepatic T1-Time Predicts Cardiovascular Risk in All-Comers Referred for Cardiovascular Magnetic Resonance: A Post-Hoc Analysis. Circ Cardiovasc Imaging. 2022 Oct;15(10):e014716. doi: 10.1161/CIRCIMAGING.122.014716. Epub 2022 Oct 18.
- 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. This study is not recruiting at the moment.
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 and Heart Failure, run by Dr. Andreas Kammerlander 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 7 Jan 2020. 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 Andreas Kammerlander, MD PhD (0043 1 40400 46140, andreas.kammerlander@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation NAFLD and liver T1mapping (time frame: cross-sectional within one year). 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 NCT04220450, 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 7 Jan 2020.