The primary objective of this study is to implement a transmural patient care pathway as recommended by the EASL guideline of June 2024, in order to identify patients with MASLD and its progressive form of MASH in primary care centres (PCC) and…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a. Steatosis stage deduced from controlled attenuation parameter (CAP)
measurement with FibroScan; MASLD definition (CAP > 280 and 1 out of 5
cardiometabolic risk factors);
b. Fibrosis stage deduced from liver stiffness measurement (LSM) by vibration
controlled transient elastography (VCTE) measurement with FibroScan
c. At-risk MASH deduced from FAST score
d. MASH diagnosis confirmed by histology (NAS/SAF criteria) upon liver biopsy;
c. Prevalences (see a. to d.) stratified per country;
d. Number of patients at-risk identified by FIB-4 in comparison to numbers
found using LSM by VCTE with FibroScan measurements, and numbers found in
combination.
Secondary outcome
1. Baseline clinical characteristics; genomic and proteomic analysis;
metabolomic and lipidomic analyses; fluxomics analysis; prevalence
comorbidities; prognostic factors;
2. PRO surveys at baseline and follow-up;
3. Revisited FibroScan measurements (CAP and LSM by VCTE) 12 weeks after of
lifestyle recommendations;
4. Repeated CAP, LSM by VCTE and FAST measurement over time.
Background summary
Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) is estimated
to be present in 30% of the world*s population, with serious complications and
multiple associated co-morbidities. However, MASLD is relatively unknown and
often diagnosed at a late stage. The current study will assist (primary) health
care providers to implement the latest patient care pathway, as described by
the European Association for the Study of Liver (EASL), to identify patients
at-risk of severe MASLD and raise awareness. Identified patients with severe
MASLD need to be monitored closely, they could be offered lifestyle
intervention and they may be candidate for upcoming treatment options.
Study objective
The primary objective of this study is to implement a transmural patient care
pathway as recommended by the EASL guideline of June 2024, in order to identify
patients with MASLD and its progressive form of MASH in primary care centres
(PCC) and clinics in 10 European countries.
Study design
10.000 high-risk patients (type 2 diabetes mellitus, metabolic syndrome,
obesity or arterial hypertension) in 10 different European countries will be
screened for the presence of MASLD, liver fibrosis and (at-risk)
metabolic-dysfunction associated steatohepatitis (MASH) using at least two
non-invasive tests (FIB-4 and FibroScan®). Additional published and exploratory
non-invasive test will also be investigated. Blood samples and liver biopsy
material will be collected following a predefined protocol. Genomic, proteomic,
metabolomic, lipidomic and fluxomic studies will be applied to gain a better
understanding of the pathophysiology of MASLD and to identify markers that will
help to detect patients at-risk.
Study burden and risks
Patients are expected to have individual benefit from the study, as potential
progressive forms of NAFLD will be diagnosed sooner and detailed follow-up and
possibly treatment will be initiated within the patient care pathway. Most
study procedures are non-invasive. A subset of the patients will undergo a
liver biopsy. This is an invasive procedure, and it may be potential harmful as
it may lead to bleeding, which would be controlled and treated according to
good clinical practice.
Broederplein 41-43
Zeist 3703CD
NL
Broederplein 41-43
Zeist 3703CD
NL
Listed location countries
Age
Inclusion criteria
- 18-75 year old;
- new or established diagnosis of at least 1 of the following 4 conditions:
type 2 diabetes mellitus, obesity, arterial hypertension or metabolic syndrome
(diagnostic criteria defined in protocol).
Exclusion criteria
- The patient is known with hepatitis B, C or HIV or any other liver condition
(like hemochromatosis, Wilson*s disease, sarcoidosis, etc);
- The patient is known with any other condition that may lead to liver fibrosis
or cirrhosis;
- The patient engages in (Excessive) alcohol use (defined as > 3 units/day in
males [30 grams/day] and > 2 units/day in females [20 grams/day]);
- The patient has a history or evidence of any other clinically significant
condition or planned or expected procedure that in the opinion of the
Investigator, may compromise the patient*s safety or ability to be included in
this study;
-The patient is an employee or contractor of the facility that is conducting
the study or is a family member of the Investigator, sub-Investigator, or any
Sponsor personnel;
- The patient is not able to understand the details of the protocol and/or is
not able to provide written informed consent;
- The patient is pregnant or breastfeeding.
- The patient underwent bariatric surgery in the last 12 months.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05651724 |
| CCMO | NL81221.100.22 |