Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT07188220
Eligibility Criteria:
Inclusion Criteria:
* Patients who voluntarily agree to participate in the MASH-Cardiovascular Programme.
* Patients followed in the outpatient hepatology/gastroenterology clinic at Hospital de Sant Pau with a diagnosis of MASH and fibrosis stage F2-F4.
* Patients aged between 18 and 75 years.
* Patients with a BMI ≥ 27 kg/m².
* Patients who consent to participate in the study-specific interviews.
Exclusion Criteria:
* Patients who do not agree to participate in the study-specific interviews.
* Patients meeting exclusion criteria of the MASH-Cardiovascular Programme:
* Patients with decompensated liver cirrhosis.
* Patients who are vegetarians or have dietary habits/preferences that prevent adherence to standard-of-care nutritional guidelines.
* Patients with moderate-to-severe alcohol consumption (\>20 g/day for women and \>40 g/day for men).
* Patients with an eGFR \< 30 mL/min.
* Patients with malnutrition.
* Patients with type 1 diabetes or other forms of diabetes.
* Patients who are candidates for bariatric surgery.
* Patients with active malignancy.
* Patients with advanced or unstable heart failure.
* Patients with eating disorders or severe psychiatric illness.
* Patients currently enrolled in another clinical trial.
* Pregnant women or women planning to become pregnant.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07188220
Study Brief:
Protocol Section:
NCT07188220