NAFLDCardio-NASHNCT04774302
Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With NAFLD
An observational study of NAFLD, run by Clinique Pasteur at 2 sites in France.
Trial summary
This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD
- How many people
- 292 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Mar 2021to 30 Apr 2025
- 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: Male or female evaluated in a dedicated hepatology day hospital, as part of a first diagnostic workup or follow-up for already known NAFLD
Who may be able to join
- NAFLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)
- Patient without known heart disease
- Patient agreeing to participate and who has given his non opposition
Who cannot join
- Association with another cause of liver disease
- Already known coronary artery disease
- Pregnancy or breastfeeding in progress
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital St Joseph
Marseille, 13285
Clinique Pasteur
Toulouse, 31 076
About this study
Official title: Study of Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With Nonalcoholic Fatty Liver Disease
This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. The study would clarify the value and the role of the Coronary calcium score (CAC score) in the screening for coronary disease in this population at high cardiovascular risk.
Read the detailed description
Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests
- Conditions
- NAFLD
- Keywords
- CAC score, Liver fibrosis, Cardiovascular risk, Metabolic syndrome
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary calcium score
Score in Agatston IU of coronary atherosclerosis risk;ranging from 0 to 100 : low risk; 100 to 400 : intermediate risk and > 400 : high risk of coronary atherosclerosis.
Measured: At inclusion
Shear wave liver elastography
Hepatic elasticity assessed in kPa : <5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; > 8 kPa : advanced fibrosis; >15 kPa : cirrhosis
Measured: At inclusion
Secondary outcomes (3)
ARFI Hepatic elasticity
Hepatic elasticity assessed by Acoustic radiation force impulse (ARFI) (in kPa) Hepatic elasticity assessed in kPa : <5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; > 8 kPa : advanced fibrosis; >15 kPa : cirrhosis .
Measured: At inclusion
Cardiovascular risk
Systemic Coronary Risk Estimation (SCORE) ranging from <1% very low risk to >15% very high risk of cardiovascular mortality
Measured: At inclusion
Coronary heart disease
Diagnosis of coronary heart disease
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start18 Mar 2021
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maeva GUILLAUME, MD, Principal investigator, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774302
- Sponsor's protocol ID
- 2020-A03423-36
- Acronym
- Cardio-NASH
- Status last verified
- Jun 2025
- First submitted
- 24 Feb 2021
- Last updated
- 6 Mar 2026
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04774302
- Acronym / sponsor ID
- Cardio-NASH / 2020-A03423-36
- Conditions
- NAFLD
- Keywords
- CAC score, Liver fibrosis, Cardiovascular risk, Metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 1 Mar 2021 (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.
This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. The study would clarify the value and the role of the Coronary calcium score (CAC score) in the screening for coronary disease in this population at high cardiovascular risk.
Detailed description
Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female evaluated in a dedicated hepatology day hospital, as part of a first diagnostic workup or follow-up for already known NAFLD
Key inclusion criteria (3 listed)
- NAFLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)
- Patient without known heart disease
- Patient agreeing to participate and who has given his non opposition
Key exclusion criteria (3 listed)
- Association with another cause of liver disease
- Already known coronary artery disease
- Pregnancy or breastfeeding in progress
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
Coronary calcium score
Time frame: At inclusion
Score in Agatston IU of coronary atherosclerosis risk;ranging from 0 to 100 : low risk; 100 to 400 : intermediate risk and > 400 : high risk of coronary atherosclerosis.
Shear wave liver elastography
Time frame: At inclusion
Hepatic elasticity assessed in kPa : <5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; > 8 kPa : advanced fibrosis; >15 kPa : cirrhosis
3 secondary outcomes
ARFI Hepatic elasticity
Time frame: At inclusion
Cardiovascular risk
Time frame: At inclusion
Coronary heart disease
Time frame: 3 month
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 6 Mar 2026.
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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.
Maeva GUILLAUME, MD principal investigator
Clinique Pasteur
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 NAFLD, run by Clinique Pasteur at 2 sites in France.
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 3 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 6 Mar 2026. 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 France. 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.
What does the primary outcome measure?
Coronary calcium score (time frame: At inclusion). The study lists 2 primary outcomes in all. 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 6 Mar 2026.