24-h-ambulatory Blood Pressure Monitoring and Pulse Wave Analysis in NAFLD Patients (NCT04543721) | Clinical Trial Compass
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24-h-ambulatory Blood Pressure Monitoring and Pulse Wave Analysis in NAFLD Patients
Germany200 participantsStarted 2019-10-01
Plain-language summary
Evaluation of the individual cardiovascular risk profile of patients with non-alcoholic fatty liver disease (NAFLD) using 24-hour ambulatory long-term blood pressure measurement and pulse wave analysis
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 18 years
* Patients with confirmed or newly diagnosed non-alcoholic fatty liver disease (NAFLD),NAFL,NASH
* Patients with arterial hypertension, without concomitant liver disease
* Patients with overweight or obesity (BMI ≥25) without fatty liver; the latter excluded in advance by current imaging
* Patients with chronic hepatitis B, chronic hepatitis C, ethyltoxic liver disease, autoimmune hepatitis, cholestatic liver disease (PBC, PSC) or other chronic hepatopathy; existing liver histology is desirable, but absence is not a criterion for exclusion All patients should be of normal weight (BMI 18.5 - 24.9) and, with the exception of alcoholic liver disease, should not have fatty liver in the imaging.
* Patients with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, colitis indeterminata)
* Healthy controls: no known previous illness, no permanent medication, no fatty liver (excluded in advance by current imaging), normal weight (BMI 18.5 - 24.9).
* Present declaration of consent
Exclusion Criteria:
* Failure to meet the inclusion criteria
* A known chronic liver disease that is not described in the above mentioned collectives
* Taking drugs that can cause fatty degeneration of the liver (e.g. methotrexate, amiodarone, tamoxifen, etc.)
* Circumstances that do not allow the person concerned to assess the nature and extent as well as possible consequences of the clinical trial
* Indications that the subject is unlikely to comply w…